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Completed

NCT Number: NCT00662623

Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

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.

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Key information

Conditions

Sleep Apnea Syndromes Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Veterans Medical Research Foundation

San Diego, California, 92161, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

i-PAP

Behavioral

Internet Intervention based on wireless telemonitoring of CPAP data and patient-centered, collaborative care

Usual Care (Standard Care)

Behavioral

Pre-determined clinic visits and telephone support

Primary outcomes

  1. CPAP Adherence

    Time frame: 4 months

Secondary outcomes

  1. Quality of patient-centered collaborative care

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Veterans Medical Research Foundation

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 21, 2008
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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