This trial is active, not recruiting.

Condition positional obstructive sleep apnea
Treatment deliver therapy when the supine position is detected
Sponsor Advanced Brain Monitoring, Inc.
Start date June 2013
End date February 2014
Trial size 45 participants
Trial identifier NCT02032706, 201301


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Deliver therapy when the supine position is detected
deliver therapy when the supine position is detected Night Shift
Application of vibrotactile feedback to the neck when the supine position is detected

Primary Outcomes

Evaluation of safety based on in-home use of the therapy
time frame: Four weeks
Evaluate efficacy based on a change in OSA severity as a result of therapy
time frame: 30-days

Secondary Outcomes

Confirmation that Night Shift accurately detects supine position
time frame: One-night
Evaluate whether Night Shift disrupts sleep such that users are non-compliant
time frame: four weeks
Evaluate whether patients adapt and sleep through the position therapy feedback
time frame: four weeks
Evaluate efficacy by confirming position therapy reduces daytime somnolence in patients with positional OSA
time frame: four weeks
Evaluate whether position therapy improves quality of life for patients with positional OSA
time frame: four weeks
Assess the accuracy of Night Shift's detection of sleep vs. wake
time frame: One night
Assess the accuracy of Night Shift's measurement of total sleep time
time frame: one night
Assess the accuracy of Night Shift measurement of sleep efficiency
time frame: one night

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

The inclusion criteria are: - be between the age of 18 and 75 years, - have been diagnosed with 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 CPAP 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 PM to 9 AM 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 COPD - 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

Additional Information

Official title Validation of Safety and Efficacy for Night Shift Therapy
Principal investigator Daniel J Levendowski, MBA
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Advanced Brain Monitoring, Inc..