CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
Armodafinil +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02552303
NCT02552303N/ACompleted
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The Treatment of Insomnia Comorbid With Sleep Disordered Breathing Using Armodafinil and/or Cognitive Behavioral Therapy for Insomnia

University of Pennsylvania·interventional·Posted Sep 17, 2015·Updated Jul 31, 2017

In Brief

A clinical study evaluating Cognitive Behavioral Therapy for Insomnia, Armodafinil, and 1 other intervention for Sleep Apnea and Insomnia. Completed, enrolled 39 participants.

Detailed Summary

The purpose of this study is to assess the effects of Armodafinil, CBT-I, or the combination of the two on the sleep continuity of persons suffering from sleep disordered breathing and their adherence to CBT-I and Continuous Positive Airway Pressure (CPAP). Adults diagnosed with obstructive sleep apnea and who meet additional research and diagnostic criteria for insomnia will be recruited. Participants will submit daily sleep diaries and supplemental questionnaires as measures of study progress.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea, Insomnia
Countries--
CollaboratorsTeva Pharmaceutical Industries, Ltd.

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 17, 2015
Enrollment StartApr 1, 2014
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.8 years ago

Interventions

Cognitive Behavioral Therapy for Insomniabehavioral

Cognitive Behavioral Therapy for Insomnia.

Armodafinildrug

Active medication

Placebodrug

Placebo for Nuvigil (armodafinil)