Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

Veterans Medical Research Foundation

Status and phase: Completed; Phase 3; Phase 2

Conditions: Sleep Apnea Syndromes

Treatments: Behavioral: i-PAP; Behavioral: Usual Care (Standard Care)

Study type: Interventional

Funder types: Other

Identifiers

NCT00662623

HS-17246-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

1

Experimental group

Treatment:

Behavioral: i-PAP

2

Active Comparator group

Description:

Usual Care (Standard Care)

Treatment:

Behavioral: Usual Care (Standard Care)