CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 281 enrolled
Drug / intervention
Continuous Positive Airway Pressure (CPAP) Treatment +1 moredevice
Likely dose
CPAP device with therapeutic pressure (exact pressure not specified; sham comparator delivers <1 cm H2O)AI-extracted
Key inclusion· 4
  • ✓Newly diagnosed obstructive sleep apnea with RDI between 5 and 30 on overnight polysomnography
  • ✓Epworth Sleepiness Scale (ESS) score greater than 11 on two separate days to confirm excessive daytime sleepiness
  • ✓Stable medical history with no medication changes in the 3 months prior to study entry
  • ✓Stable psychiatric history with no psychotropic medication changes in the 3 months prior to study entry
Key exclusion· 14
  • ✕Presence of another sleep disorder in addition to OSA (e.g., periodic limb movement disorder >10 movements/hour with arousal, central sleep apnea ≥5 central apneas, insomnia, sleep hypoventilation, or narcolepsy)
  • ✕Previous OSA treatment with CPAP, oral appliance, home oxygen, uvulopalatopharyngoplasty, tracheotomy, or other OSA surgery
  • ✕Oxygen or bi-level CPAP required for OSA treatment
  • ✕Medically unstable condition in the 3 months prior (e.g., myocardial infarction, heart failure, Cheyne-Stokes breathing, unstable angina, uncontrolled thyroid disease, unstable diabetes, depression/psychosis, ventricular arrhythmias, cirrhosis, recently diagnosed cancer)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT00089752N/ACompleted
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Impact of CPAP on Functional Outcomes in Milder Obstructive Sleep Apnea (CATNAP)

University of Pennsylvania·interventional·Posted Aug 16, 2004·Updated Jul 24, 2017

In Brief

A clinical study evaluating Continuous Positive Airway Pressure (CPAP) Treatment and Sham CPAP device - CPAP device with pressure delivered <1 cm H20 for Lung Diseases and 2 related conditions. Completed, enrolled 281 participants across 5 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine whether functional status improves in individuals with milder obstructive sleep apnea (OSA) following continuous positive airway pressure (CPAP) treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Diseases, Sleep Apnea Syndromes, Hypertension
CountriesCanada, United States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Respironics Sleep and Respiratory Foundation, Cephalon

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 16, 2004
Enrollment StartSep 1, 2003
Primary CompletionAug 1, 2008
Study CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 21.9 years ago

Interventions

Continuous Positive Airway Pressure (CPAP) Treatmentdevice

CPAP device used at night

Sham CPAP device - CPAP device with pressure delivered <1 cm H20device

Sham CPAP device used at night