CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,105 enrolled
Drug / intervention
Active CPAP +1 moredevice
Likely dose
Nightly nasal continuous positive airway pressure (CPAP) at individualized therapeutic pressureAI-extracted
Key inclusion· 2
  • ✓Male or female adults age 18 years or older
  • ✓Diagnosis of OSAS using clinical criteria defined by the study protocol
Key exclusion· 9
  • ✕Prior treatment for OSAS with continuous positive airway pressure or surgery
  • ✕Cardiac/cardiovascular complications: low blood oxygen, congestive heart failure, history of angina, coronary artery disease, myocardial infarction, stroke, or cardiac rhythm disturbance
  • ✕Use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications affecting neurocognitive function and alertness
  • ✕Chronic neurological disorders affecting neurocognitive abilities or daily function

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

Search/NCT00051363
NCT00051363Phase 3Completed
CompareCT.gov

APPLES: Apnea Positive Pressure Long-Term Efficacy Study

Stanford University·interventional·Posted Jan 13, 2003·Updated Nov 28, 2018

In Brief

A Phase 3 clinical trial evaluating Active CPAP and Sham CPAP for Lung Diseases and 2 related conditions. Completed, enrolled 1,105 participants across 5 sites.

Detailed Summary

The purpose of this study is to determine the effectiveness of nasal continuous positive airway pressure (CPAP) therapy for the treatment of obstructive sleep apnea syndrome (OSAS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Diseases, Sleep Apnea Syndromes, Sleep
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 13, 2003
Enrollment StartSep 1, 2002
Primary CompletionAug 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 23.5 years ago

Interventions

Active CPAPdevice

Nightly nasal continuous positive airway pressure (CPAP)

Sham CPAPdevice

Sham CPAP machine will be used for participants in the placebo group.