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| ID | Type | Description | Link |
|---|---|---|---|
| 299-JF-23 | Other Grant/Funding Number | American Academy of Sleep Medicine (AASM) Foundation |
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| Name | Class |
|---|---|
| American Academy of Sleep Medicine | OTHER |
| Case Western Reserve University | OTHER |
| MetroHealth Medical Center | OTHER |
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This study has two parts: an observational part and an interventional part.
The goal of the observational part of the study is to look for variations in swallowing in adults with obstructive sleep apnea (OSA) and in adults who don't snore. The main questions it aims to answer are:
This may help us better understand what causes OSA, which may help us develop alternate ways to treat or even prevent OSA. It may also help us improve care for people with OSA who struggle with CPAP. Participants will be aged 40-60 years, except women up to the age of 70 will be included in the healthy control (non-snorer) group.
Participants will:
Undergo a type of x-ray study called a modified barium swallow study (MBS)
Come to MetroHealth Medical Center for a measurement visit to:
Complete some questionnaires
For successful CPAP users: we will download data from the chip in their CPAP device
Do a home sleep test (except for successful CPAP users who have had a recent in-lab sleep test)
The goal of the interventional part of the study is to test swallowing exercises in people ages 40-60 years with OSA who struggle with CPAP. The main question it aims to answer is:
• Can swallowing exercises help people who struggle with CPAP sleep better with CPAP?
Participants will:
Obstructive sleep apnea (OSA) is a common disorder in which the throat narrows abnormally or even collapses fully during sleep. The narrowing leads to sleep disruption and increases the risk of many chronic health conditions. We do not understand why the throat narrows in some people during sleep but not in others. While being overweight or obese increases a person's risk of OSA, it is only one part of the problem. Some thin adults and children have OSA, and many overweight or obese people do not have OSA. In addition, many people with OSA struggle to benefit from current OSA treatments like continuous positive airway pressure (CPAP), which uses air pressure to hold the airway open during sleep. We need improved understanding of OSA in order to improve treatment of it.
The throat is used for swallowing as well as for breathing. Hence it should not be surprising if a throat that has trouble staying open during sleep might also have some abnormalities during swallowing. Indeed, some research has shown subtle abnormalities in swallowing in people who have snoring or OSA compared to people who don't snore at all. We would like to further develop this line of research.
This study has two arms: an observational arm to look for differences in swallowing, and an interventional arm to see if swallowing exercises can improve people's ability to use CPAP.
The purpose of the observational arm is to look for differences in swallowing between healthy people and people who have obstructive sleep apnea (OSA) using a variety of measurement techniques, some of which have not been done in the past. Understanding the differences in swallowing may help us to develop new treatments for OSA. It may also help us to figure out how to prevent OSA from developing in the first place. We are also looking to see if there are swallowing differences between people with OSA who don't tolerate CPAP compared to people who do well with CPAP. If there are differences, these differences may help us better understand why some people do not tolerate CPAP, and may lead to the development of novel treatments such as exercise therapies to help them do better with CPAP.
The interventional arm will test exercise therapies to see if they will help people who struggle with CPAP. The goal is not to cure OSA, but to help people be able to use CPAP better so that they can sleep better. Participants who have abnormalities in their swallowing study will get exercises from speech language pathologists (SLP, also known as speech therapists) aimed at trying to correct those abnormalities. Participants will then try to use CPAP again. Participants who still can't sleep well with CPAP after those exercises, or who don't have abnormalities on the swallowing study, will get another type of exercise therapy based on an exercise technique called orofacial myofunctional therapy (OMT). This therapy aims to train exclusive nasal breathing and correct variations in the swallow. This sort of exercise technique has had some success in improving CPAP use as well as in reducing the severity of OSA. We have created a streamlined exercise protocol based on these techniques that we hope will provide better results in a shorter period of time. At the end of the exercise interventions, the participants will repeat the investigations that were done at the beginning of the study.
Investigations will include home sleep testing, CPAP trials (only for participants with OSA and CPAP intolerance), a modified barium swallow study (MBS), a measurement visit, and questionnaires. During the measurement visit, there will be assessments of the strength of the tongue, lips, and cheeks, assessment of nasal airflow, respiratory muscle strength, restrictions in tongue mobility (tongue tie), posture, dental and facial form, and eating and drinking. The modified barium swallow study uses x-rays; the amount of radiation from the procedure is about what a person would receive from about 4.5 months of background radiation. It is a little bit more radiation than what a person would receive from a mammogram, but much less than what a person would receive from a CT scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy airways group | No Intervention | Participants will get a home sleep test to verify that sleep disordered breathing is not present. They will do a modified barium study (MBS) and a measurement visit to assess oral and respiratory muscle strength, nasal airflow, tongue mobility, eating and drinking, dental and facial form, and posture. They will also fill out some questionnaires. | |
| Successful CPAP user | No Intervention | Participants who do well will CPAP will do a modified barium study (MBS) and a measurement visit to assess oral and respiratory muscle strength, tongue mobility, nasal airflow, eating and drinking, dental and facial form, and posture. They will also fill out some questionnaires. Participants will also provide their CPAP data on an SD card. Participants will also do a home sleep test if there is no recent sleep study available. | |
| CPAP intolerant - SLP exercises only | Experimental | CPAP intolerant participants will try to use CPAP for two weeks with individualized coaching. If they still have problems with CPAP, they will do a modified barium study (MBS), a baseline home sleep test, and a measurement visit. During the measurement visit their oral and respiratory strength, nasal airflow, tongue mobility, eating and drinking, dental and facial form, and posture will be assessed. They will also fill out questionnaires. Participants with abnormalities on their MBS will get a 7-week course of standard swallowing exercises, with weekly in-person visits with a speech pathologist. They will be expected to do daily exercises (which will take 20-30 minutes). They will then try to use CPAP for two weeks to see if they are able to use CPAP better. If they do well with CPAP or are still struggling with CPAP but do not want to continue onto the myofunctional therapy arm, they will do an MBS, home sleep test, questionnaires, and the measurement visit again. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLP swallowing exercises | Other | Clinical speech language pathologists will provide standard exercises based on the abnormalities seen on the modified barium swallow. Exercises are expected to include the effortful swallow, the Mendelsohn maneuver, expiratory muscle strength training with the EMST-150, supraglottic swallow, super supraglottic swallow, chin tuck against resistance isokinetic exercise, chin tuck against resistance isometric exercise, Masako maneuver, Shaker isometric head lift exercise, Shaker isokinetic head lift exercise, Falsetto high pitch glide exercise, tongue press exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of premature spillage in participants with OSA who are CPAP intolerant vs participants who are successful nasal CPAP users or who have healthy airways | MBS images will be evaluated for premature spillage during oral bolus formation. Comparison of prevalence of premature spillage will be made between study groups. | at the time of MBS (within 2-4 weeks of study enrollment) |
| Effect of swallowing exercise intervention for CPAP intolerance | The effect of a swallowing exercise intervention on CPAP intolerance will be assessed, as reflected by change in usage from the participants' own pre-treatment CPAP data. The results of the two exercise interventions will be pooled, as the goal is to see if swallowing exercises can improve CPAP tolerance rather than to compare therapies. | 3-7 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline length of the oropharyngeal seal during bolus formation in the modified barium swallow study (MBS) | The length of the oropharyngeal seal during bolus formation will be measured to assess for differences between participants with healthy airways and those with OSA. | at the time of MBS (within 2-4 weeks of study enrollment) |
| Measure | Description | Time Frame |
|---|---|---|
| Long term outcome of swallowing exercise intervention on average nightly hours of CPAP use (participants with CPAP intolerance only) | Assess long-term impact of goal-oriented oromuscular rehabilitation in OSA participants with CPAP intolerance by following up on average nightly hours of CPAP use with CPAP compliance downloads and phone follow-up, to be done 3, 6, and 12 months after the end of the final CPAP trial. |
Inclusion Criteria for healthy airways participants:
Inclusion Criteria for participants with OSA who are successful CPAP users:
Inclusion Criteria for participants with OSA who have CPAP intolerance:
Exclusion Criteria for all participants:
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| Name | Affiliation | Role |
|---|---|---|
| Denise Dewald, MD | MetroHealth Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
All IDP collected throughout the trial.
Beginning year 1 after first publication with no end date.
No data use agreement or data request will be required.
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D020247 | Myofunctional Therapy |
| ID | Term |
|---|---|
| D012049 | Rehabilitation of Speech and Language Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| CPAP intolerant - OMT exercises only | Experimental | CPAP intolerant participants will try to use CPAP for two weeks with individualized coaching. If they still have problems with CPAP, they will do a modified barium study (MBS), a baseline home sleep test, and also a measurement visit. During the measurement visit their oral and respiratory strength, tongue mobility, nasal airflow, eating and drinking, dental and facial form, and posture will be assessed. They will also fill out some questionnaires. CPAP intolerant participants without abnormalities on their MBS will get oral myofunctional therapy (OMT) exercises. The course of exercises will take 7 weeks to complete, with weekly video follow up visits. The exercises will take 20-30 minutes to do over the course of the day. After completing the 7-week course, participants will repeat the home sleep test, modified barium study, questionnaires, and measurement visit, and will once more try using CPAP for two weeks to see if they are able to use CPAP better. |
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| CPAP intolerant - SLP and OMT | Experimental | CPAP intolerant participants will try to use CPAP for two weeks with individualized coaching. If they still have problems with CPAP, they will do a modified barium study (MBS), a baseline home sleep test, and also a measurement visit. During the measurement visit their oral and respiratory strength, nasal airflow, tongue mobility, eating and drinking, dental and facial form, and posture will be assessed. They will also fill out questionnaires. Participants with abnormalities on their MBS will get standard swallowing exercises based on the abnormalities. They will then try using CPAP for two weeks. If they do not improve their CPAP tolerance with standard swallowing exercises, they will do a course of myofunctional therapy exercises. Both courses will be 7 weeks long, with daily exercises to do at home lasting 20-30 min. They will then repeat the home sleep test, MBS, questionnaires, and measurement visit, and will try using CPAP for two weeks to see if they can use CPAP better. |
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| myofunctional exercises | Other | Participants will get a variety of exercises aimed at improving bolus formation, strengthening the seal of the soft palate with the tongue, and habituating nasal breathing. There will also be exercises aimed at stabilizing the epiglottis and strengthening the muscles supporting the lateral pharyngeal walls. Expiratory muscle strength training with the EMST-150 will also be done. |
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| Baseline breathing route during wakefulness as assessed by MBS |
Breathing route (oral, oronasal, or nasal) will be determined by soft palate position during resting breathing under fluoroscopy in the modified barium swallow study. Comparison will be made between healthy airways, CPAP intolerant, and successful CPAP user groups. |
| at the time of MBS (within 2-4 weeks of study enrollment) |
| Baseline tongue position as observed during nasal breathing during MBS | A high or low tongue resting position during nasal breathing will be noted upon review of the MBS images. Tongue position will be compared between study groups. | at the time of MBS (within 2-4 weeks of study enrollment) |
| Baseline soft palate shape as observed during nasal breathing during MBS | Assessment of the angulation of the soft palate during nasal breathing will be performed. Results will be compared between healthy airways, CPAP intolerant, and successful CPAP user groups. | at the time of MBS (within 2-4 weeks of study enrollment) |
| Baseline assessment of Tipper- vs Dipper-type oral swallowing | The presence of Tipper-type vs Dipper-type oral swallowing will be assessed by MBS. The prevalence of the oral swallowing types in the study groups will be compared. | at the time of MBS (within 2-4 weeks of study enrollment) |
| Baseline assessment of anterior tongue strength | Assessment of anterior tongue strength will be made using an IOPI (Iowa Oral Performance Index) system. Strength will be compared between groups. | at the time of the measurement visit (within 2-4 weeks of study enrollment); participants with CPAP intolerance will have a second measurement visit at the end of the study |
| Baseline assessment of posterior tongue strength | Assessment of posterior tongue strength will be made using an IOPI (Iowa Oral Performance Index) system. Strength will be compared between groups. | at the time of the measurement visit (within 2-4 weeks of study enrollment) |
| Baseline assessment of combined lip/cheek strength | Assessment of combined lip/cheek strength will be made using an IOPI (Iowa Oral Performance Index) system. Strength will be compared between groups. | at the time of the measurement visit (within 2-4 weeks of study enrollment) |
| Baseline assessment of combined lip/cheek activation during swallowing | Assessment of combined lip/cheek activation during swallowing will be made using an IOPI (Iowa Oral Performance Index) system. Extent of combined lip/cheek activation during swallowing will be compared between groups. | at the time of the measurement visit (within 2-4 weeks of study enrollment) |
| Baseline maximum expiratory pressure | Maximum expiratory pressure (MEP) will be assessed and compared between study groups. | at the time of the measurement visit (within 2-4 weeks of study enrollment) |
| Baseline maximum inspiratory pressure via oral route | Maximum inspiratory pressure by the oral route will be assessed and compared between study groups. | at the time of the measurement visit (within 2-4 weeks of study enrollment) |
| Baseline sniff inspiratory pressure (SNIP) via nasal route | Baseline maximum sniff inspiratory pressure (SNIP) by the nasal route will be assessed and compared between study groups. | at the time of the measurement visit (within 2-4 weeks of study enrollment) |
| Baseline awake resting breathing route assessment by nasal pressure signal | Awake breathing route (oral, oronasal, or nasal) will be inferred by nasal pressure signal during resting breathing. Comparison will be made between healthy airways, CPAP intolerant, and successful CPAP user groups. | at the time of the measurement visit (within 2-4 weeks of study enrollment) |
| Baseline assessment of Mallampati score | Mallampati score will be assessed by physical examination. Comparisons will be made between study groups. | at the time of the measurement visit (within 2-4 weeks of study enrollment) |
| Baseline assessment of Friedman tongue position score | Friedman tongue position score will be assessed by physical examination. Comparisons will be made between study groups. | at the time of the measurement visit (within 2-4 weeks of study enrollment) |
| Baseline anterior tongue tie evaluation | Anterior tongue tie evaluation will be made using the tongue tie assessment tool. Comparisons between groups will be made. | at the time of the measurement visit (within 2-4 weeks of study enrollment) |
| Baseline posterior tongue tie evaluation | Posterior tongue tie evaluation will be made using the tongue tie assessment tool. Comparisons between groups will be made. | at the time of the measurement visit (within 2-4 weeks of study enrollment) |
| Baseline visual differences in swallowing | Utilization of lip and cheek muscles during swallowing will be assessed visually (with videorecording). Comparisons will be made between the study groups. | at the time of the measurement visit (within 2-4 weeks of study enrollment) |
| Baseline head tilt angle differences | Head tilt angle will be measured by glasses with an attached digital level. Comparisons will be made between study groups. | at the time of the measurement visit (within 2-4 weeks of study enrollment) |
| Baseline postural assessment | Photographs will be taken with the participant standing next to a plumb line for postural assessment. Comparisons will be made between study groups. | at the time of the measurement visit (within 2-4 weeks of study enrollment) |
| Baseline CPAP waveform differences between participants with CPAP intolerance and participants who are successful CPAP users (participants with OSA only) | CPAP waveforms will be assessed for the presence of negative effort dependence or other differences in the airflow waveform shapes in participants with CPAP intolerance compared to participants who are successful nasal CPAP users. | At study enrollment (successful CPAP users) or after baseline 2-week CPAP trial (participants with CPAP intolerance), within 1 months of enrollment |
| Baseline differences in nasal pressure signal during sleep between participants with CPAP intolerance and participants who are successful CPAP users (participants with OSA only) | Nasal pressure waveforms during sleep will be assessed for the presence of negative effort dependence or other features that may be different between participants with CPAP intolerance compared to participants who are successful nasal CPAP users, as seen in polysomnography or home sleep testing. | At enrollment (if recent PSG is already available) or after completion of home sleep testing, within one month of enrollment |
| Baseline Swallowing Disturbance Questionnaire | Participants will complete the Swallowing Disturbance Questionnaire. Responses will be compared between study groups. | When baseline questionnaires are returned, within one month of enrollment. |
| Baseline Epworth Sleepiness Scale (ESS) | Participants will complete the Epworth Sleepiness Scale (ESS) questionnaire. Comparisons will be made between study groups. | When baseline questionnaires are returned, within one month of enrollment. |
| Baseline Pittsburgh Sleep Quality Index (PSQI) questionnaire | Participants will complete the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Comparisons will be made between study groups. | When baseline questionnaires are returned, within one month of enrollment. |
| Baseline Insomnia Severity Index (ISI) questionnaire | Participants will complete the Insomnia Severity Index (ISI) questionnaire. Comparisons will be made between study groups. | When baseline questionnaires are returned, within one month of enrollment. |
| Baseline Short Calgary Sleep Apnea Quality Of Life Index questionnaire | Participants will complete the Short Calgary Sleep Apnea Quality Of Life Index questionnaire. Comparisons will be made between study groups. | When baseline questionnaires are returned, within one month of enrollment. |
| Baseline Short Form Health Survey-36 questionnaire | Participants will complete the Short Form Health Survey-36 questionnaire. Comparisons will be made between study groups. | When baseline questionnaires are returned, within one month of enrollment. |
| Baseline PROMIS Sleep Disturbance short form 8b questionnaire | Participants will complete the PROMIS Sleep Disturbance short form 8b questionnaire. Comparisons will be made between study groups. | When baseline questionnaires are returned, within one month of enrollment. |
| Baseline PROMIS Sleep-related impairment short form 8a questionnaire | Participants will complete the PROMIS Sleep-related impairment short form 8a questionnaire. Comparisons will be made between study groups. | When baseline questionnaires are returned, within one month of enrollment. |
| Baseline sleep habits and swallowing and CPAP observations questionnaire | Participants will complete questionnaires on sleep habits and swallowing and CPAP observations. Responses will be compared between study groups. | When baseline questionnaires are returned, within one month of enrollment. |
| Post-intervention assessment of AHI by home sleep testing (participants with CPAP intolerance only) | Repeat home sleep testing will be performed after the final swallowing exercise intervention has been completed (before the CPAP trial or two weeks after the CPAP trial). Results will be compared with the participant's baseline home sleep test. | Before the post-intervention CPAP trial or two weeks after the CPAP trial, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention changes in nasal airflow during sleep (participants with CPAP intolerance only) | Nasal pressure signal on home sleep testing will be assessed for changes in flow limitation and negative effort dependence after the intervention, and compared to the participant's pre-intervention waveforms. | Before the post-intervention CPAP trial or two weeks after the CPAP trial, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention assessment of pulse oxygen nadir by home sleep testing (participants with CPAP intolerance only) | Repeat home sleep testing will be performed after the final swallowing exercise intervention has been completed (before the CPAP trial or two weeks after the CPAP trial). Pulse oxygen nadir will be determined and compared with the participant's baseline home sleep test. | Before the post-intervention CPAP trial or two weeks after the CPAP trial, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention assessment of time with oxygen saturation less than 90% during home sleep testing (participants with CPAP intolerance only) | Repeat home sleep testing will be performed after the final swallowing exercise intervention has been completed (before the CPAP trial or two weeks after the CPAP trial). The time spent with oxygen saturation less than 90% will be determined and compared with the participant's baseline home sleep study. | Before the post-intervention CPAP trial or two weeks after the CPAP trial, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention differences in nasal pressure signal during home sleep testing (participants with CPAP intolerance only) | Post-intervention nasal pressure waveforms during home sleep testing will be assessed for the presence of negative effort dependence or other changes. Results will be compared to participant's baseline results and to those of participants who are successful nasal CPAP users, as seen in polysomnography or home sleep testing. | After the post-intervention 2-week CPAP trial, 3-7 months after study enrollment |
| Post-intervention assessment of oral bolus formation during MBS (participants with CPAP intolerance only) | Repeat MBS after the swallowing exercise intervention will be done to assess for any changes in oral bolus formation/premature spillage. | Within 2-4 weeks of the completion of the final swallowing exercise intervention, which will be 3-7 months after enrollment |
| Post-intervention length of oropharyngeal seal during bolus formation in modified barium swallow study (MBS) (participants with CPAP intolerance only) | The length of the oropharyngeal seal during oral bolus formation will be measured on MBS. Results will be compared to the participant's baseline MBS. | at the time of the post-intervention MBS, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention breathing route during wakefulness by MBS (participants with CPAP intolerance only) | Breathing route (oral, oronasal, or nasal) will be determined by soft palate position during resting breathing under fluoroscopy in the repeat modified barium swallow study, to be done after completion of the final exercise intervention. Comparison will be made to the participant's baseline results. | at the time of the post-intervention MBS, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention tongue position as observed during nasal breathing during MBS (participants with CPAP intolerance only) | A high or low tongue resting position during nasal breathing will be noted upon review of the MBS images. Tongue position will be compared to participant's baseline results. | at the time of the post-intervention MBS, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention soft palate shape as observed during nasal breathing during MBS (participants with CPAP intolerance only) | Assessment of the angulation of the soft palate during nasal breathing will be performed. Results will be compared to the participant's baseline. | at time of the post-intervention MBS, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention assessment of Tipper- vs Dipper-type swallowing (participants with CPAP intolerance only) | The presence of Tipper-type vs Dipper-type oral swallowing will be assessed by repeat MBS. The results will be compared to the participant's baseline. | at the time of the post-intervention MBS, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention assessment of anterior tongue strength (participants with CPAP intolerance only) | Assessment of anterior tongue strength will be made using an IOPI (Iowa Oral Performance Index) system during the post-intervention measurement visit. Strength will be compared to participant's baseline and to baseline results for the other study groups. | at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention assessment of posterior tongue strength (participants with CPAP intolerance only) | Assessment of posterior tongue strength will be made using an IOPI (Iowa Oral Performance Index) system during the post-intervention measurement visit. Strength will be compared to participant's baseline and to baseline results for the other study groups. | at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention assessment of combined lip/cheek strength (participants with CPAP intolerance only) | Assessment of combined lip/cheek strength will be made using an IOPI (Iowa Oral Performance Index) system during the post-intervention measurement visit. Strength will be compared to participant's baseline and to baseline results for the other study groups. | at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention assessment of combined lip/cheek activation during swallowing (participants with CPAP intolerance only) | Repeat assessment of combined lip/cheek activation during swallowing will be made using an IOPI (Iowa Oral Performance Index) system. Extent of lip/cheek activation during swallowing will be compared to participant's baseline results and also to the baseline results of the other study groups. | at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention maximum expiratory pressure (participants with CPAP intolerance only) | Maximum expiratory pressure (MEP) will be assessed post-intervention and compared to participant's baseline and the baseline results of the other study groups. | at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention maximum inspiratory pressure via oral route (participants with CPAP intolerance only) | Maximum inspiratory pressure by the oral route will be assessed post-intervention. Results will be compared to participant's baseline results and to baseline results of other study groups. | at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention sniff inspiratory pressure (SNIP) via nasal route (participants with CPAP intolerance only) | Post-intervention maximum sniff inspiratory pressure (SNIP) by the nasal route will be assessed. Results will be compared to participant's baseline values and between those of the other study groups. | at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention awake resting breathing route assessment by nasal pressure signal (participants with CPAP intolerance only) | Post-intervention awake breathing route (oral, oronasal, or nasal) will be determined by nasal pressure signal during resting breathing. Comparison will be made to participant's baseline results and to those of the other study groups. | at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention assessment of Mallampati score (participants with CPAP intolerance only) | Post-intervention Mallampati score will be assessed by physical examination. Comparisons will be made to participant's baseline value and to the Mallampati scores of the other study groups. | at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention assessment of Friedman tongue position score (participants with CPAP intolerance only) | Post-intervention Friedman tongue position score will be assessed by physical examination. Comparisons will be made to participant's baseline score and also to scores of the other study groups. | at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention anterior tongue tie evaluation (participants with CPAP intolerance only) | Repeat anterior tongue tie evaluation will be made using the tongue tie assessment tool. Comparisons to participant's baseline results and the results of other study groups will be made. | at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention posterior tongue tie evaluation (participants with CPAP intolerance only) | Post-intervention posterior tongue tie evaluation will be made using the tongue tie assessment tool. Result will be compared to participant's baseline result and to the results of the other study groups. | at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention visual differences in swallowing (participants with CPAP intolerance only) | Post-intervention utilization of lip and cheek muscles during swallowing will be assessed visually (with videorecording). Comparisons will be made to the participant's baseline results and to the results of the other study groups. | at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention head tilt angle differences (participants with CPAP intolerance only) | Post-intervention head tilt angle will be measured by glasses with an attached digital level. Comparisons will be made to participant's baseline value and to those of the other study groups. | at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention postural assessment (participants with CPAP intolerance only) | Post-intervention photographs will be taken with the participant standing next to a plumb line for postural assessment. Comparisons will be made to participant's baseline results and to those of the other study groups. | at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention CPAP waveform differences (participants with CPAP intolerance only) | After the final 2-week CPAP trial, CPAP waveforms will be obtained from the CPAP data chip and assessed for the presence of negative effort dependence or other differences in the airflow waveform shapes. Results will be compared to participant's pre-intervention results and those of participants who are successful nasal CPAP users. | After the post-intervention 2-week CPAP trial, 3-7 months after study enrollment. |
| Post-intervention CPAP residual AHI (participants with CPAP intolerance only) | Residual AHI will be collected from the CPAP data chip after 2-week CPAP trial at the end of the swallowing exercise intervention. Results will be compared to participant's pre-intervention results and those of participants who are successful nasal CPAP users. | After the post-intervention 2-week CPAP trial, 3-7 months after study enrollment. |
| Post-intervention number of nightly CPAP mask removals (participants with CPAP intolerance only) | The number of nightly CPAP mask removals will be collected from the CPAP data chip after 2-week CPAP trial at the end of the swallowing exercise intervention. Results will be compared to participant's pre-intervention results and those of participants who are successful nasal CPAP users. | After the post-intervention 2-week CPAP trial, 3-7 months after study enrollment. |
| Post-intervention Swallowing Disturbance Questionnaire (participants with CPAP intolerance only) | Participants will complete a second Swallowing Disturbance Questionnaire after completing the final exercise intervention. Responses will be compared to their baseline questionnaire. | When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention Epworth Sleepiness Scale (ESS) (participants with CPAP intolerance only) | Participants will complete a second Epworth Sleepiness Scale (ESS) questionnaire after completing the final exercise intervention. Comparison will be made to the participant's baseline results. | When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention Pittsburgh Sleep Quality Index (PSQI) questionnaire (participants with CPAP intolerance only) | Participants will complete a second Pittsburgh Sleep Quality Index (PSQI) questionnaire after completing the final exercise intervention. Comparison will be made to participant's baseline results. | When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention Insomnia Severity Index (ISI) questionnaire (participants with CPAP intolerance only) | Participants will complete a second Insomnia Severity Index (ISI) questionnaire after completing the final exercise intervention. Comparison will be made to participant's baseline results. | When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention Short Calgary Sleep Apnea Quality Of Life Index questionnaire (participants with CPAP intolerance only) | Participants will complete a second Short Calgary Sleep Apnea Quality Of Life Index questionnaire after completing the final exercise intervention. Comparison will be made to participant's baseline results. | When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention Short Form Health Survey-36 questionnaire (participants with CPAP intolerance only) | Participants with CPAP intolerance will complete a second Short Form Health Survey-36 questionnaire after completion of the exercise intervention(s). Comparisons will be made to their responses on the baseline questionnaire. | When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention PROMIS Sleep Disturbance short form 8b questionnaire (participants with CPAP intolerance only) | Participants will complete a second PROMIS Sleep Disturbance short form 8b questionnaire after completing the final exercise intervention. Comparison will be made to participant's baseline results. | When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention PROMIS Sleep-related impairment short form 8a questionnaire (participants with CPAP intolerance only) | Participants will complete a second PROMIS Sleep-related impairment short form 8a after completing the final exercise intervention. Comparison will be made to participant's baseline results. | When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| Post-intervention sleep habits and swallowing and CPAP observations questionnaire (participants with CPAP intolerance only) | Participants will complete repeat questionnaires on sleep habits and swallowing and CPAP observations after completing the final exercise intervention. Comparison will be made to participant's baseline results. | When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done |
| 3-15 months after completion of the final exercise intervention (depending on whether participant will need a CPAP device) |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D003813 | Dentistry |