Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea
CATNAP
Impact of CPAP on Functional Outcomes in Milder Obstructive Sleep Apnea (CATNAP)
2 other identifiers
interventional
281
2 countries
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2003
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 12, 2004
CompletedFirst Posted
Study publicly available on registry
August 16, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
July 24, 2017
CompletedJuly 24, 2017
June 1, 2017
4.9 years
August 12, 2004
September 18, 2009
June 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment
The primary endpoint is change after 8 weeks of treatment from baseline value (controlling for baseline value) in the 30-item Functional Outcomes of Sleep Questionnaire (FOSQ) that will be used to test the primary study hypothesis that patients with milder OSA (RDI 5-30) on active treatment will demonstrate greater mean change for the Total score from baseline to 8 weeks treatment. The FOSQ is designed to assess the impact of excessive sleepiness on functional status. The instrument has established content validity, test-retest reliability (r= 0.91), and internal consistency (alpha = 0.96). The scale ranges from 5 - 20 with normal functional status being a value greater than 17.
8 weeks
Secondary Outcomes (6)
Change in the Score From Baseline to 8 Weeks Treatment Epworth Sleepiness Scale
Measured at Baseline and Week 8 of treatment in ITT sample
Change in Mean Arterial Daytime Pressure at Baseline and Week 8 Treatment
Measured at Baseline and Week 8 treatment in the ITT sample
Change in the Score From Baseline to 8 Weeks Treatment Measured by the Profile of Mood States
Measured at Baseline and Week 8 treatment in the ITT sample
Change in the Number of Lapses From Baseline to 8 Weeks Treatment on the Psychomotor Vigilance Task (PVT) - Total Lapses in 20 Minute Test
Baseline and 8 weeks of treatment in the ITT sample
Change in the Score From Baseline to 8 Weeks Treatment on the SF36 - Physical
Baseline and Week 8 of treatment in ITT sample.
- +1 more secondary outcomes
Study Arms (2)
Active Treatment
ACTIVE COMPARATORContinuous Positive Airway Pressure Treatment
Sham/Placebo Treatment
PLACEBO COMPARATORIneffective sham continuous positive airway pressure device with leak in interface to \<1.0 cm H2O and resistance in motor to simulate normal operating noise and no compensation for leak.
Interventions
CPAP device used at night
Sham CPAP device used at night
Eligibility Criteria
You may qualify if:
- Newly diagnosed with OSA on overnight polysomnogram (PSG) with RDI between 5 and 30
- Score of greater than 11 on the Epworth Sleepiness Scale (ESS) on two administrations of the instrument (performed at prescreening and screening), each completed on a different day to avoid sporadic values and confirm the presence of excessive daytime sleepiness
- Stable medical history and no change in medications, including hypertension medications, in the 3 months prior to study entry
- Stable psychiatric history and no change in psychotropic medications in the 3 months prior to study entry
- Has access to a telephone
You may not qualify if:
- Diagnosis of another sleep disorder in addition to OSA based on PSG, e.g., periodic limb movement disorder (greater than 10 limb movements per hour of sleep with arousal); central sleep apnea (greater than 5 or more central apneas); insomnia; sleep hypoventilation syndrome; or narcolepsy
- Previous treatment for sleep apnea with nasal CPAP, oral appliance, home oxygen therapy, uvulopalatopharyngoplasty, tracheotomy, or other surgery for OSA
- Oxygen or bi-level CPAP required for treatment of OSA
- Unable to return for study instructions or follow-up testing
- Medically unstable condition (e.g., heart attack, congestive heart failure, Cheyne-Stokes breathing, unstable angina, uncontrolled thyroid disease, unstable diabetes, depression or psychosis, ventricular arrhythmias, cirrhosis, or recently diagnosed cancer) in the 3 months prior to study entry
- Regular use (greater than 3 times per week) of sedative, hypnotic, or alerting medications (such as Modafinil) in the 3 months prior to study entry
- Chronic nasal congestion that would prevent the use of a nasal mask, in the 3 months prior to study entry
- History of automobile accidents due to excessive daytime sleepiness
- Employed in transportation-related safety sensitive occupation such as an airline pilot, truck driver, or train engineer
- Night shift worker regularly experiencing jet lag, or a history of irregular work schedules in the 6 months prior to study entry
- Regular use of alcohol as determined by answering yes to one or more of the questions on the CAGE questionnaire (i.e., alcohol dependent)
- Recent or recurring history of substance abuse leading to tolerance or dependence
- Pregnant; women must either be postmenopausal or confirmed not pregnant by a urine pregnancy test
- Unable to perform study tests, e.g., inability to communicate verbally; inability to write and read in English; less than a 5th grade reading level (evaluated using Flesch-Kincaid assessment); visual impairment; hearing impairment; cognitive impairment (e.g., previous head injury); or upper extremity motor deficit (e.g., previous stroke or spinal cord injury)
- Residing with an individual who is currently using CPAP treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Respironics Sleep and Respiratory Foundationcollaborator
- Cephaloncollaborator
Study Sites (5)
National Jewish Medical and Research Center (NJC)
Denver, Colorado, 80206, United States
Emory University School of Medicine (EMO)
Atlanta, Georgia, 30329, United States
North Shore-Long Island Jewish Health System (LIJ)
Long Island City, New York, 11040, United States
New York University Medical School
New York, New York, 10016, United States
University of Western Ontario (UWO)
London, Ontario, Canada
Related Publications (2)
Weaver TE, Mancini C, Maislin G, Cater J, Staley B, Landis JR, Ferguson KA, George CF, Schulman DA, Greenberg H, Rapoport DM, Walsleben JA, Lee-Chiong T, Gurubhagavatula I, Kuna ST. Continuous positive airway pressure treatment of sleepy patients with milder obstructive sleep apnea: results of the CPAP Apnea Trial North American Program (CATNAP) randomized clinical trial. Am J Respir Crit Care Med. 2012 Oct 1;186(7):677-83. doi: 10.1164/rccm.201202-0200OC. Epub 2012 Jul 26.
PMID: 22837377RESULTRodway GW, Weaver TE, Mancini C, Cater J, Maislin G, Staley B, Ferguson KA, George CF, Schulman DA, Greenberg H, Rapoport DM, Walsleben JA, Lee-Chiong T, Kuna ST. Evaluation of sham-CPAP as a placebo in CPAP intervention studies. Sleep. 2010 Feb;33(2):260-6. doi: 10.1093/sleep/33.2.260.
PMID: 20175410DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Post-randomization adverse events are summarized by treatment arm \& body system.The CTC-AE (Publish Date December 12, 2003) was utilized for coding verbatim (raw) adverse event data with a MedDRA code, Body System, AE/Supraordinate term \& Grade.
Results Point of Contact
- Title
- Terri E. Weaver, PhD, RN, FAAN
- Organization
- University of Pennsylvania School of Nursing
Study Officials
- STUDY CHAIR
Terri Weaver
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2004
First Posted
August 16, 2004
Study Start
September 1, 2003
Primary Completion
August 1, 2008
Study Completion
November 1, 2008
Last Updated
July 24, 2017
Results First Posted
July 24, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will share
Petition of Principal Investigator with document outlining purpose of secondary analysis and use of the data, which is then reviewed with co-investigators for overall approval.