Validation of Safety and Efficacy for Night Shift Therapy

Obstructive Sleep Apnea Clinical Trial

Official title:

Validation of Safety and Efficacy for Night Shift Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032706
• Other study ID #: 201301
• Status: Completed
• Phase: N/A
• First received: January 8, 2014
• Last updated: February 3, 2016
• Start date: June 2013
• Est. completion date: February 2014

Study information

• Verified date: June 2014
• Source: Advanced Brain Monitoring, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• Deliver therapy when the supine position is detected
Application of vibrotactile feedback to the neck when the supine position is detected

Locations

Country	Name	City	State
United States	Complete Sleep Solutions	Murrieta	California

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Brain Monitoring, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Four weeks	Yes
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.	30-days	No
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).	baseline	No
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.	four weeks	No
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	four weeks	No
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.	baseline and followup	No
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.	four weeks	No
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.	baseline and follow-up	No
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.	one night	No
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	one night	No

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