Validation of Safety and Efficacy for Night Shift Therapy

Not Applicable

Completed

Conditions: Obstructive Sleep Apnea

Interventions: Device: Deliver therapy when the supine position is detected

Registration Number: NCT02032706

Lead Sponsor: Advanced Brain Monitoring, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

Inclusion Criteria

Not provided

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Positional feedback	Deliver therapy when the supine position is detected	Deliver therapy when the supine position is detected

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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.
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.
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