Mode
Text Size
Log in / Sign up
N/A N=281 Randomized Double-blind Treatment

Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea

Lung Diseases · Sleep Apnea Syndromes · Hypertension

Enrolled (actual)
281
Serious AEs
7.1%
Results posted
Jul 2017
Primary outcome: Primary: Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment — 0.98; -0.14 scores on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Continuous Positive Airway Pressure (CPAP) Treatment (Device); Sham CPAP device - CPAP device with pressure delivered <1 cm H20 (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Pennsylvania
Primary completion
Aug 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment
0.98; -0.14
SECONDARY
Change in the Score From Baseline to 8 Weeks Treatment Epworth Sleepiness Scale
-2.58; -0.54
SECONDARY
Change in Mean Arterial Daytime Pressure at Baseline and Week 8 Treatment
90.3; 92 0.09
SECONDARY
Change in the Score From Baseline to 8 Weeks Treatment Measured by the Profile of Mood States
-10.2; -0.5
SECONDARY
Change in the Number of Lapses From Baseline to 8 Weeks Treatment on the Psychomotor Vigilance Task (PVT) - Total Lapses in 20 Minute Test
-2.91; 2.99
SECONDARY
Change in the Score From Baseline to 8 Weeks Treatment on the SF36 - Physical
3.92; -0.19
SECONDARY
Change in the Score From Baseline to 8 Weeks Treatment SF-36 Mental Component
3.38; 2.00

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00089752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search