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Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

This study has been completed.
Information provided by (Responsible Party):
Carl J. Stepnowsky, Veterans Medical Research Foundation Identifier:
First received: April 16, 2008
Last updated: May 12, 2016
Last verified: May 2016
The purpose of this study is to examine the effect of different methods of providing education about sleep apnea and continuous positive airway pressure therapy (CPAP) use and how that education might help to improve health outcomes and the amount of time CPAP is used.

Condition Intervention Phase
Sleep Apnea Syndromes Behavioral: i-PAP Behavioral: Usual Care (Standard Care) Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

Resource links provided by NLM:

Further study details as provided by Carl J. Stepnowsky, Veterans Medical Research Foundation:

Primary Outcome Measures:
  • CPAP Adherence [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Quality of patient-centered collaborative care [ Time Frame: 4 months ]

Estimated Enrollment: 200
Study Start Date: April 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: i-PAP
Internet Intervention based on wireless telemonitoring of CPAP data and patient-centered, collaborative care
Active Comparator: 2
Usual Care (Standard Care)
Behavioral: Usual Care (Standard Care)
Pre-determined clinic visits and telephone support

Detailed Description:
Poor treatment adherence with CPAP therapy is well-documented. Set against a backdrop of telemedicine applications that have grown as fast in unsubstantiated claims and assumptions of patient satisfaction, diagnostic accuracy, clinical efficacy, and cost-effectiveness as they have in technological sophistication and capabilities, the evaluative aspect of this proposal is designed as as a randomized, controlled clinical trial—Usual Care patients (control) versus i-PAP patients (intervention). An important empirical-methodological advantage of the project is the objective measurement of CPAP adherence, which is measured by internal microprocessor as the "amount of time CPAP is used at the prescribed pressure." This objective measurement allows feedback of treatment adherence and efficacy to both patient and provider, and the i-PAP intervention was designed around this central feature.

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

Inclusion Criteria:

  • age > 18 years
  • confirmed diagnosis of OSA
  • being newly prescribed CPAP therapy
  • having chronic symptoms as noted on screening symptom checklist
  • fluency in English

Exclusion Criteria:

  • cognitive impairment sufficient to cause inability to complete the protocol (MMSE < 24/30)
  • residence in a geographical area outside of San Diego County
  • fatal comorbidity (life expectancy less than 6 months as indicated by treating physician)
  • significant documented substance/chemical abuse or other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment
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Please refer to this study by its identifier: NCT00662623

United States, California
Veterans Medical Research Foundation
San Diego, California, United States, 92161
Sponsors and Collaborators
Veterans Medical Research Foundation
Principal Investigator: Carl J. Stepnowsky, PhD Veterans Medical Research Foundation
  More Information

Responsible Party: Carl J. Stepnowsky, Study PI, Veterans Medical Research Foundation Identifier: NCT00662623     History of Changes
Other Study ID Numbers: HS-17246-01
Study First Received: April 16, 2008
Last Updated: May 12, 2016

Keywords provided by Carl J. Stepnowsky, Veterans Medical Research Foundation:
Chronic Obstructive Sleep Apnea
Sleep Apnea
Sleep Apnea Treatment

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on September 21, 2017