Status:
COMPLETED
Portable Monitoring for Diagnosis and Management of Sleep Apnea
Lead Sponsor:
Case Western Reserve University
Collaborating Sponsors:
University Hospitals Cleveland Medical Center
The Cleveland Clinic
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 pressu...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
373 Patients enrolled
Trial Details
Trial ID
NCT00642486
Start Date
February 1 2008
End Date
March 1 2010
Last Update
August 5 2025
Active Locations (1)
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1
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106