Obstructive Sleep Apnea
Conditions
Keywords
obstructive sleep apnea, position therapy, snoring, positional
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDeliver therapy when the supine position is detected
Application of vibrotactile feedback to the neck when the supine position is detected
Sponsors
Advanced Brain Monitoring, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
The inclusion criteria are: * be between the age of 18 and 75 years, * have been diagnosed with Obstructive Sleep Apnea (OSA) during polysomnography at a designated sleep center within 4 months of their enrollment, * have not received treatment with any OSA therapy for more than 3 days within the past month, * have an overall Apnea-Hypopnea Index (AHI) \> 10 and hypopneas requiring \>3% oxygen desaturation, * having a non-supine Apnea-Hypopnea Index (AHI) \< 15 if Continuous Positive Airway Pressure has not been attempted, * have a overall AHI divided by the non-supine AHI \> 1.5, * had an Epworth Sleepiness Score of 5 or more at the time of diagnosis and at the start of therapy, * Change in weight of no more than 5 pounds since the diagnostic PSG * access to a computer and the Internet * sleep is sometime between 8 P.M. to 9 A.M. Monday through Friday in the same bed
Exclusion criteria
* Neck, back or should pain which would impact ability to sleep laterally each night * Body mass index \> 35 * suffering from neurological disorders which result in ticks or tremors * diagnosed with congestive heart failure or chronic obstructive pulmonary disease * suffered from a stroke within the previous 12 months * taking or planning to take narcotic medications * unfamiliar with use of internet browsers * travel (i.e., foreign or cruise ship) which would limit internet or mail access * planned medical procedures (e.g., surgery) which would limit device use during the scheduled 30-day study period or introduce the need for narcotic pain medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events | Four weeks | 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. |
| Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy | 30-days | Determine the percentage of participants that exhibited at least a 50% reduction in OSA severity measured by AHI after 4 weeks of therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback | four weeks | 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 |
| Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA | baseline and followup | 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. |
| Evaluate Impact of Positional Therapy on Quality of Life Scores | four weeks | 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. |
| Confirmation That Night Shift Accurately Detects Supine Position | baseline and 4-weeks later at follow up | 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). |
| Assess the Accuracy of Night Shift's Measurement of Total Sleep Time | one night | 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. |
| Assess the Accuracy of Night Shift Measurement of Sleep Efficiency | one night | 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 |
| Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake | baseline and follow-up | 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. |
| Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant | four weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not qualify | 5 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Positional Feedback |
|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 9.4 |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
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.
Time frame: 30-days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Positional Feedback | Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy | 83 percentage of participants |
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.
Time frame: Four weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Positional Feedback | Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events | 100 Percentage of participants |
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
Time frame: one night
Population: Studies included 35 baseline comparisons and 30 comparisons at follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Positional Feedback | Assess the Accuracy of Night Shift Measurement of Sleep Efficiency | 92 % studies |
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.
Time frame: baseline and follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positional Feedback | Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake | Sensitivity sleep baseline | 88.7 percentage of epochs | Standard Deviation 8.9 |
| Positional Feedback | Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake | Sensitivity sleep followup | 91.3 percentage of epochs | Standard Deviation 8 |
| Positional Feedback | Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake | Specificity wake baseline | 55.0 percentage of epochs | Standard Deviation 17.7 |
| Positional Feedback | Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake | Specificity wake followup | 61.2 percentage of epochs | Standard Deviation 16.5 |
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.
Time frame: one night
Population: Comparisons included 35 studies at baseline and 30 follow-up studies
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Positional Feedback | Assess the Accuracy of Night Shift's Measurement of Total Sleep Time | 98 % of studies |
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).
Time frame: baseline and 4-weeks later at follow up
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Positional Feedback | Confirmation That Night Shift Accurately Detects Supine Position | Baseline accuracy n=35 | 91 percentage of participants |
| Positional Feedback | Confirmation That Night Shift Accurately Detects Supine Position | Followup accuracy n=30 | 93 percentage of participants |
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.
Time frame: baseline and followup
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Positional Feedback | Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA | 50 percentage of participants |
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.
Time frame: four weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Positional Feedback | Evaluate Impact of Positional Therapy on Quality of Life Scores | 57 Percentage of participants |
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.
Time frame: four weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Positional Feedback | Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant | 96 Percent of nights |
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
Time frame: four weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Positional Feedback | Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback | 97 % participants averaged < 15% supine |