Validation of Safety and Efficacy for Night Shift Therapy

N/ACompletedNCT02032706

Advanced Brain Monitoring, Inc.36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Deliver therapy when the supine position is detectedDEVICE

Application of vibrotactile feedback to the neck when the supine position is detected

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Complete Sleep Solutions

Murrieta, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Four weeks

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.

Time frame: 30-days

Secondary Outcomes

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).

Time frame: baseline and 4-weeks later at follow up

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.

Time frame: four weeks

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

Time frame: four weeks

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.

Data from ClinicalTrials.gov

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