Clinical trial NCT02032706: Validation of Safety and Efficacy for Night Shift Therapy
Official title: Validation of Safety and Efficacy for Night Shift Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
position therapy
snoring
positional
Lead sponsor: Advanced Brain Monitoring, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events
timeFrame: Four weeks
measure: Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy
timeFrame: 30-days
Secondary outcomes:
measure: Confirmation That Night Shift Accurately Detects Supine Position
timeFrame: baseline and 4-weeks later at follow up
measure: Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant
timeFrame: four weeks
measure: Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback
timeFrame: four weeks
measure: Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA
timeFrame: baseline and followup
measure: Evaluate Impact of Positional Therapy on Quality of Life Scores
timeFrame: four weeks
measure: Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake
timeFrame: baseline and follow-up
measure: Assess the Accuracy of Night Shift's Measurement of Total Sleep Time
timeFrame: one night
measure: Assess the Accuracy of Night Shift Measurement of Sleep Efficiency
timeFrame: one night
Other outcomes:
Locations:
city: Murrieta
country: United States
facility: Complete Sleep Solutions
state: California
Study officials:
affiliation: Advanced Brain Monitoring, Inc.
name: Daniel J Levendowski, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.