Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring

• ClinicalTrials.gov Identifier: NCT00682838
• Recruitment Status: Completed
• First Posted: May 22, 2008
• Results First Posted: September 1, 2016
• Last Update Posted: September 1, 2016
• Sponsor: VA Office of Research and Development
• Collaborator: University of California, San Diego
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief Summary:

Obstructive sleep apnea (OSA) is a major chronic condition affecting the quality of life of up to one-fifth of all Veterans. Because of disappointingly low adherence to the gold-standard treatment (continuous positive airway pressure therapy - CPAP), the Institute of Medicine has stated that new adherence strategies are needed that improve the quality of care, reduce social and economic costs, and help OSA patients live happier, healthier, and more productive lives through improved clinical management. The combination of a self-management approach along with emerging wireless technologies has strong potential to increase treatment adherence and improve outcomes.

Condition or disease	Intervention/treatment	Phase
Sleep Apnea Syndromes	Behavioral: Self-management; Behavioral: Telemonitored care	Phase 2; Phase 3

Detailed Description:

The Sleep Apnea Self-Management Program (SASMP) was evaluated by conducting a randomized, controlled trial of the program compared to Usual Care in patients diagnosed with OSA and prescribed CPAP therapy. Participants randomized to the SASMP group attended 4 weekly educational sessions of approximately two hours each. A trained leader facilitated the program from a scripted manual. Key topics covered in this program included: (1) management of OSA symptoms, CPAP side effects, and weight loss; (2) maintaining social contacts and family relationships; and (3) dealing with symptoms of depression and worries about the future.

The primary aim of this study was to examine the effect of the SASMP, compared to Usual Care, on CPAP adherence. It is hypothesized that SASMP participants will have higher levels of CPAP adherence compared to those in the Usual Care group.

A second aim of the study was to examine the effect of the SASMP, compared to Usual Care, on proposed mediating variables derived from social cognitive theory (perceived self-efficacy, outcome expectations). It is hypothesized that SASMP participants would have higher levels of self-efficacy and outcome expectations compared to the Usual Care group.

And the third aim of the study was to measure the short- and long-term effects of the SASMP, compared to Usual Care, on health outcomes (e.g., OSA symptoms and OSA-specific HRQOL). It is hypothesized that improvements in OSA symptoms and OSA-specific HRQOL will be seen both initially and as maintained 6 months and 1 year after the start of the SASMP.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 280 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Treatment
• Official Title: Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring
• Study Start Date: July 2009
• Actual Primary Completion Date: May 2012
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Self-Management (SM); Active Intervention - Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective	Behavioral: Self-management; Self-management
Active Comparator: Telemonitored Care (TC); Active Comparator - Telemonitored care: Telemonitored care Consists of CPAP therapist actively monitoring care at a distance, and acting on that data per a set protocol	Behavioral: Telemonitored care; Telemonitored care
Experimental: SM + TC; Self-management and Telemonitored care: Combination of both SM + TC intervention	Behavioral: Self-management; Self-management; Behavioral: Telemonitored care; Telemonitored care
No Intervention: Usual care (UC); Control Group

Outcome Measures

Primary Outcome Measures :

1. Nightly CPAP Adherence [ Time Frame: 3 mos ]
   Nightly CPAP adherence hours per night measured over the three-months period

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion criteria were:

1. Diagnosis of OSA
2. Prescription for CPAP treatment by a sleep physician
3. Being CPAP naïve (ie, no previous use of CPAP).

Exclusion criteria were:

1. Residence in a geographical area outside of San Diego County
2. Fatal comorbidity (life expectancy less than 6 months as indicated by treating physician)
3. Significant documented substance/chemical abuse

Contacts and Locations

Locations

United States, California

VA San Diego Healthcare System

San Diego, California, United States, 92161

Sponsors and Collaborators

VA Office of Research and Development

University of California, San Diego

Investigators

• Principal Investigator: Carl J Stepnowsky, PhD; San Diego Veterans Healthcare System

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00682838
• Other Study ID Numbers: IIR 07-163; 080139 ( Other Identifier: UCSD IRB )
• First Posted: May 22, 2008
• Results First Posted: September 1, 2016
• Last Update Posted: September 1, 2016
• Last Verified: July 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:

Treatment compliance; Self-management; Telemedicine

Additional relevant MeSH terms:

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