Trial Outcomes & Findings for Validation of Safety and Efficacy for Night Shift Therapy (NCT NCT02032706)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

Four weeks

Results posted on

2016-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	36
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Did not qualify	5
Overall Study Protocol Violation	1

Baseline Characteristics

Validation of Safety and Efficacy for Night Shift Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Positional Feedback n=36 Participants 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
Age, Continuous	50 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Positional Feedback n=30 Participants 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
Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events	100 Percentage of participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Positional Feedback n=30 Participants 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
Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy	83 percentage of participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Positional Feedback n=35 Participants 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
Confirmation That Night Shift Accurately Detects Supine Position Baseline accuracy n=35	91 percentage of participants
Confirmation That Night Shift Accurately Detects Supine Position Followup accuracy n=30	93 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Positional Feedback n=30 Participants 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
Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant	96 Percent of nights Interval 71.0 to 100.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Positional Feedback n=30 Participants 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
Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback	97 % participants averaged < 15% supine

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Positional Feedback n=30 Participants 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
Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA	50 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Positional Feedback n=30 Participants 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
Evaluate Impact of Positional Therapy on Quality of Life Scores	57 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Positional Feedback n=35 Participants 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
Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake Sensitivity sleep baseline	88.7 percentage of epochs Standard Deviation 8.9
Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake Sensitivity sleep followup	91.3 percentage of epochs Standard Deviation 8.0
Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake Specificity wake baseline	55.0 percentage of epochs Standard Deviation 17.7
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 outcome

Timeframe: one night

Population: Comparisons included 35 studies at baseline and 30 follow-up studies

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.

Outcome measures

Outcome measures
Measure	Positional Feedback n=35 Participants 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
Assess the Accuracy of Night Shift's Measurement of Total Sleep Time	98 % of studies

SECONDARY outcome

Timeframe: one night

Population: Studies included 35 baseline comparisons and 30 comparisons at follow-up

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

Outcome measures

Outcome measures
Measure	Positional Feedback n=35 Participants 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
Assess the Accuracy of Night Shift Measurement of Sleep Efficiency	92 % studies

Adverse Events

Positional Feedback

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Levendowski

Advanced Brain Monitoring, Inc.

Phone: 760 720 0099

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place