Validation of Safety and Efficacy for Night Shift Therapy

Advanced Brain Monitoring

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Device: Deliver therapy when the supine position is detected

Study type

Interventional

Funder types

Industry

Identifiers

NCT02032706

201301

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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