Validation of Safety and Efficacy for Night Shift Therapy

NCT02032706 | Completed Results

• 1 other identifier: 201301
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; position therapy; snoring; positional

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (8)

• Confirmation That Night Shift Accurately Detects Supine Position

  baseline and 4-weeks later at follow up

• Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant

  four weeks

• Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback

  four weeks

• Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA

  baseline and followup

• Evaluate Impact of Positional Therapy on Quality of Life Scores

  four weeks

Study Arms (1)

Positional feedback

EXPERIMENTAL

Deliver therapy when the supine position is detected

Device: Deliver therapy when the supine position is detected

Interventions

Deliver therapy when the supine position is detected DEVICE

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

Also known as: Night Shift

Positional feedback

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Advanced Brain Monitoring, Inc.: lead

Study Sites (1)

Complete Sleep Solutions

Murrieta, California, 92563, United States

Location

Related 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.

  PMID: 25126032 BACKGROUND

• 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.

  PMID: 24599632 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Snoring

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Daniel Levendowski
• Organization: Advanced Brain Monitoring, Inc.

dan@b-alert.com

760 720 0099

Study Officials

• Daniel J Levendowski, MBA

  Advanced Brain Monitoring, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 10, 2014
• Study Start: June 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 1, 2016
• Results First Posted: March 2, 2016

Record last verified: 2014-06

Locations

US (1)