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| Name | Class |
|---|---|
| American Academy of Dental Sleep Medicine | UNKNOWN |
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The aim of the study is to evaluate the effectiveness of the under-mattress monitoring device to aid in the titration process of a mandibular advancement device (MAD) for the management of obstructive sleep apnea (OSA). A secondary aim is to evaluate changes in subjective OSA symptoms and patient's satisfaction with MAD. A third aim is to analyze if there are differences between the sleep parameters recorded by the under-mattress monitor between responders and non-responders to MAD therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panthera DSAD mandibular advancement device users | Experimental | Participants of the study that have been referred to the Orofacial Pain Clinic by their sleep physician for the management of their obstructive sleep apnea with a mandibular advancement device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Under-mattress monitor | Device | the under-mattress monitor will be used in conjunction with the Alice NightOne at the beginning and end of the study, in addition, the under-mattress monitor will be used daily during sleep with the intraoral device in situ |
| Measure | Description | Time Frame |
|---|---|---|
| Change in apnea-hypopnea index (AHI). | Number of apneas and hypopneas per hour of sleep which is an indicator of severity of sleep apnea, (5< normal, 5-15 Mild, 15-30 moderate, <30 severe) | Baseline and post-intervention (approximately 12 weeks) |
| Change in minimum oxygen desaturation level | The minimum O2 level percentage during treatment | Baseline and post-intervention (approximately 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Epworth Sleepiness Scale | This scale measures daytime sleepiness. Scores range from 0-24. Higher scores indicate more severe daytime sleepiness. | Baseline and post-intervention (approximately 12 weeks) |
| Change in Quality of Life Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sumia Alyousef, BDS | Contact | (859) 323-3440 | Sumia.Alyousef@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Isabel Moreno Hay, DDS, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Recruiting | Lexington | Kentucky | 40506 | United States |
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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 |
|---|---|
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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|
| level 3 Home Sleep Apnea Test | Device | Home sleep apnea test with Alice NightOne will be used for one day during sleep at the beginning and end of the study in conjunction with the Sleeptracker AI and the intraoral device. |
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| Mandibular Advancement Device (MAD) | Device | CAD-CAM, US Food and Drug Administration (FDA)-approved MAD, duo-bloc, customized, titratable sleep appliance. Participants will return every 2 weeks to the Orofacial Pain (OFP) clinic to progressively titrate the MAD advancement as needed until the under-mattress monitor scores an AHI < 5 |
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Quality of life (15D questionnaire) with 15 question items with 5 alternatives in each. The scores range between 15 to 75 with 15 the best and 75 the worst quality of life.
| Baseline and post-intervention (approximately 12 weeks) |
| Change in Fatigue Assessment Scale | The scale consists of 10 questions about the characteristics of fatigue in the current daily routine. The scale scores range from 10-50, with higher score indicating higher level of fatigue. | Baseline and post-intervention (approximately 12 weeks) |
| Change in Pittsburgh Sleep Quality Index (PSQI) | The PSQI is a 19-item questionnaire that includes seven areas of sleep quality and patterns in adults over the last month including the following components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, SDs, use of sleeping medications, and daytime dysfunction. Each item in the scale is scored from 0 to 3 scale (0 = no difficulty; 3 = severe difficulty). The scores are added to yield a global score ranging from 0 to 21 (0 = no difficulty; 21 = severe difficulties in all areas). A high total scale score indicates poor sleep quality. | Baseline and post-intervention (approximately 12 weeks) |
| Change in Snore Outcomes Survey (SOS) | SOS consists of eight items related to the frequency, duration, severity, and consequences associated with sleep-disordered breathing and specifically snoring. Respondents use several Likert-type scales to answer questions regarding their snoring, with lower scores indicating more acute problems with SDB. Scores are normalized on a scale from 0 to 100. | Baseline and post-intervention (approximately 12 weeks) |
| Short Assessment of Patient Satisfaction | Patient satisfaction with MAD will be measured by a 7-item questionnaire scored on a Likert type scale. Scores range from 7 to 35. Higher scores equate to greater satisfaction. | Post Intervention, approximately week 12 |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |