Portable Monitoring for Diagnosis and Management of Sleep Apnea (HomePAP)

Case Western Reserve University

Status: Completed

Conditions: Sleep Apnea, Obstructive

Treatments: Other: Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex); Other: Standard polysomnography (PSG)

Study type: Interventional

Funder types: Other

Identifiers

NCT00642486

ASMF 38-PM-07

Details and patient eligibility

About

This multi-site project compares compares the efficiency of a home-based portable monitoring strategy to a standard of care sleep laboratory-based strategy for the diagnosis and positive airway pressure treatment of obstructive sleep apnea in adults.

Full description

The study is a randomized, parallel group, unblinded, multicenter study that compares two approaches [home-based, portable monitoring (PM) versus attended, laboratory-based polysomnography (PSG) (Lab)] in adults, at least 18 years of age, with a moderate to high probability of obstructive sleep apnea (OSA) and who have been referred to sleep medicine specialists at AASM-accredited sleep centers for evaluation and/or management. The study is designed to compare the utility of the two approaches (PM group vs. Lab group) for the diagnosis and management of OSA in adults. Approximately 372 eligible adults will be randomized at screening to either the PM or Lab arm (186 per arm), undergo baseline OSA testing to confirm diagnosis and study eligibility, then receive positive airway pressure (PAP) titration studies to determine the level of pressure needed to treat their OSA. For qualifying participants, the titration study will be lab-based in the Lab group and be home-based using a commercially available portable, automatic PAP device (APAP) in the PM group. All qualifying study participants will have access to study CPAP equipment and supplies to treat their OSA. Primary outcomes (time from diagnosis to effective treatment, patient outcomes, and relative resource utilization) are determined at 1 and 3 months after starting CPAP treatment. Study participants who complete all of their study visits will keep their CPAP machine at the end of the study.

Enrollment: 373 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Intermediate to high probability of having OSA based on an adjusted neck circumference > 43 cm (17 inches)
• Presence of excessive daytime sleepiness (Epworth sleepiness scale ≥ 12) Apnea-hypopnea index >= 15 on diagnostic testing to continue in study

Exclusion criteria

• Severe chronic insomnia, other condition with < 4 hrs of sleep per night
• Unstable medical conditions
• Major psychiatric diagnosis
• Unable to undergo home testing
• Concerns about unsafe driving
• Severe COPD or restrictive lung disease
• Chronic narcotic use
• Alcohol abuse
• History of cataplexy
• Moderate to severe restless legs syndrome symptoms
• Pre-existing diagnosis of sleep apnea
• Prior experience with positive airway pressure treatment of sleep apnea
• Anticipated upper airway surgery or gastric bypass surgery in 4 months
• Decisional impairment for consenting
• Hypoventilation syndrome, identified in the medical record
• Waking oxygen saturation < 92%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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373 participants in 2 patient groups

1

Active Comparator group

Description:

laboratory-based testing

Treatment:

Other: Standard polysomnography (PSG)

2

Active Comparator group

Description:

home-based testing

Treatment:

Other: Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex)