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Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00662623
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : May 13, 2016
Information provided by (Responsible Party):
Carl J. Stepnowsky, Veterans Medical Research Foundation

Brief Summary:
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 or disease Intervention/treatment Phase
Sleep Apnea Syndromes Behavioral: i-PAP Behavioral: Usual Care (Standard Care) Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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
Study Start Date : April 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00662623

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United States, California
Veterans Medical Research Foundation
San Diego, California, United States, 92161
Sponsors and Collaborators
Veterans Medical Research Foundation
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Principal Investigator: Carl J. Stepnowsky, PhD Veterans Medical Research Foundation
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Responsible Party: Carl J. Stepnowsky, Study PI, Veterans Medical Research Foundation Identifier: NCT00662623    
Other Study ID Numbers: HS-17246-01
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Keywords provided by Carl J. Stepnowsky, Veterans Medical Research Foundation:
Chronic Obstructive Sleep Apnea
Sleep Apnea
Sleep Apnea Treatment
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases