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The purpose of this study is to assess the accuracy of Night Shift in the detection of supine sleep and efficacy of vibro-tactile feedback in restricting supine sleep.
The protocol is designed to first evaluate the accuracy of supine vs. non-supine detection in 15 subjects (hereafter referred to as study 1). In study 2, patients who had completed a baseline polysomnography (PSG) with a minimum of four hours of sleep time were to wear the Night Shift for two nights without feedback to confirm their willingness to continue with the study, followed by 28 nights of vibro-tactile position therapy. A follow-up PSG was to be conducted as soon as possible to the completion of the 28-nights of treatment. During enrollment subjects were to complete pre-treatment questionnaires designed to measure daytime sleepiness, insomnia severity, depression, anxiety, and quality of life. The same instruments were completed post-treatment on the morning after the 28th night of treatment. Subjects completed daily logs to confirm device utilization and identify potential non-device related factors that could influence study completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positional feedback | Experimental | Deliver therapy when the supine position is detected |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deliver therapy when the supine position is detected | Device | Application of vibrotactile feedback to the neck when the supine position is detected |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events | Assess the potential for adverse events by evaluating whether more than 20% of participants chose to terminate the study prior to completing 4 weeks of therapy. | Four weeks |
| Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy | Determine the percentage of participants that exhibited at least a 50% reduction in OSA severity measured by AHI after 4 weeks of therapy. | 30-days |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmation That Night Shift Accurately Detects Supine Position | Compute the percentage of participants at baseline and at followup in which the Night Shift's measurement of the supine position was within+/- 5% of the percent time supine by video recordings plus chest sensor (gold standard). | baseline and 4-weeks later at follow up |
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The inclusion criteria are:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel J Levendowski, MBA | Advanced Brain Monitoring, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complete Sleep Solutions | Murrieta | California | 92563 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25126032 | Background | Levendowski DJ, Seagraves S, Popovic D, Westbrook PR. Assessment of a neck-based treatment and monitoring device for positional obstructive sleep apnea. J Clin Sleep Med. 2014 Aug 15;10(8):863-71. doi: 10.5664/jcsm.3956. | |
| 24599632 | Background | Levendowski DJ, Veljkovic B, Seagraves S, Westbrook PR. Capability of a neck worn device to measure sleep/wake, airway position, and differentiate benign snoring from obstructive sleep apnea. J Clin Monit Comput. 2015 Feb;29(1):53-64. doi: 10.1007/s10877-014-9569-3. Epub 2014 Mar 6. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Positional Feedback | Deliver therapy when the supine position is detected Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
36 subjects were studied at baseline, 5 were dropped due to not meeting the required continuation criteria, 1 was dropped due to not following the protocol requirements. Follow-up PSG studies were conducted and data are available from the 30 participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Positional Feedback | Deliver therapy when the supine position is detected Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events | Assess the potential for adverse events by evaluating whether more than 20% of participants chose to terminate the study prior to completing 4 weeks of therapy. | Posted | Number | Percentage of participants | Four weeks |
|
|
Throughout the study duration i.e., four weeks of use
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Positional Feedback | Deliver therapy when the supine position is detected Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Levendowski | Advanced Brain Monitoring, Inc. | 760 720 0099 | x6040 | dan@b-alert.com |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012913 | Snoring |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant |
Measure the percentage of nights across the 4 weeks of therapy the Night Shift was worn for a minimum of 5.5 hours/night or the length of time in bed by each participant. |
| four weeks |
| Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback | Evaluate the percent time supine across four weeks of use and confirm that participants average less than 15% time supine across the four weeks of home use | four weeks |
| Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA | The percentage of compliant participants who show an improved Epworth Sleepiness Score of >= 2 after 4 weeks of therapy when compared to the baseline score. Epworth scores range from 0 (no daytime somnolence) to 21 being extreme somnolence. A difference of 2 or more indicates some positive benefit from therapy. | baseline and followup |
| Evaluate Impact of Positional Therapy on Quality of Life Scores | Compare the Functional Outcomes of Sleep (FOSQ) scores obtained at baseline and compare to results after 4 weeks of therapy to determine the percentage of compliant participants who demonstrate >2 point improvement. The FOSQ includes thirty questions with numerically scaled responses which are totaled with an overall score of 1 identifying the most impaired and 120 identifying the least impaired. | four weeks |
| Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake | Compare the epochs staged wake and sleep by the reference standard (polysomnography) to the epochs staged wake and sleep by Night Shift to determine the sleep (sensitivity) and wake (specificity) classification accuracy. | baseline and follow-up |
| Assess the Accuracy of Night Shift's Measurement of Total Sleep Time | Compared the Total Sleep Time (TST) from polysomnography to the Night Shift TST to tally the number of records with differences outside the range (151 to -129) defined by the predicate device. | one night |
| Assess the Accuracy of Night Shift Measurement of Sleep Efficiency | Compare Sleep Efficiency (SE) obtained from PSG and compared to the Night Shift SE to determine if outliers are within the range (19.1 to -17.2%) defined by the predicate device | one night |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy | Determine the percentage of participants that exhibited at least a 50% reduction in OSA severity measured by AHI after 4 weeks of therapy. | Posted | Number | percentage of participants | 30-days |
|
|
|
| Secondary | Confirmation That Night Shift Accurately Detects Supine Position | Compute the percentage of participants at baseline and at followup in which the Night Shift's measurement of the supine position was within+/- 5% of the percent time supine by video recordings plus chest sensor (gold standard). | 35 subjects completed the baseline polysomnography (PSG) while wearing the device. One subject's PSG study was conducted prior to enrollment but qualified as a baseline. 30 subjects completed a follow-up PSG. | Posted | Number | percentage of participants | baseline and 4-weeks later at follow up |
|
|
|
| Secondary | Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant | Measure the percentage of nights across the 4 weeks of therapy the Night Shift was worn for a minimum of 5.5 hours/night or the length of time in bed by each participant. | Posted | Median | Full Range | Percent of nights | four weeks |
|
|
|
| Secondary | Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback | Evaluate the percent time supine across four weeks of use and confirm that participants average less than 15% time supine across the four weeks of home use | Posted | Number | % participants averaged < 15% supine | four weeks |
|
|
|
| Secondary | Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA | The percentage of compliant participants who show an improved Epworth Sleepiness Score of >= 2 after 4 weeks of therapy when compared to the baseline score. Epworth scores range from 0 (no daytime somnolence) to 21 being extreme somnolence. A difference of 2 or more indicates some positive benefit from therapy. | Posted | Number | percentage of participants | baseline and followup |
|
|
|
| Secondary | Evaluate Impact of Positional Therapy on Quality of Life Scores | Compare the Functional Outcomes of Sleep (FOSQ) scores obtained at baseline and compare to results after 4 weeks of therapy to determine the percentage of compliant participants who demonstrate >2 point improvement. The FOSQ includes thirty questions with numerically scaled responses which are totaled with an overall score of 1 identifying the most impaired and 120 identifying the least impaired. | Posted | Number | Percentage of participants | four weeks |
|
|
|
| Secondary | Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake | Compare the epochs staged wake and sleep by the reference standard (polysomnography) to the epochs staged wake and sleep by Night Shift to determine the sleep (sensitivity) and wake (specificity) classification accuracy. | Posted | Mean | Standard Deviation | percentage of epochs | baseline and follow-up |
|
|
|
| Secondary | Assess the Accuracy of Night Shift's Measurement of Total Sleep Time | Compared the Total Sleep Time (TST) from polysomnography to the Night Shift TST to tally the number of records with differences outside the range (151 to -129) defined by the predicate device. | Comparisons included 35 studies at baseline and 30 follow-up studies | Posted | Number | % of studies | one night |
|
|
|
| Secondary | Assess the Accuracy of Night Shift Measurement of Sleep Efficiency | Compare Sleep Efficiency (SE) obtained from PSG and compared to the Night Shift SE to determine if outliers are within the range (19.1 to -17.2%) defined by the predicate device | Studies included 35 baseline comparisons and 30 comparisons at follow-up | Posted | Number | % studies | one night |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Specificity wake followup |
|