NCT02552303|CompletedResults
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Sponsor study identifier
interventional
39
0 countries
N/A
Study Start
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2015
Actual (reported)Study Completion
July 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
July 2015
Actual (reported)July 2015
Actual (reported)September 9, 2015
Actual (reported)September 17, 2015
Actual (reported)July 31, 2017
Actual (reported)The Change in Sleep Continuity From Baseline to Follow-up, as Measured by the Insomnia Severity Index (ISI).
This outcome measure is based on changes in sleep continuity, as assessed by the Insomnia Severity Index (ISI), which is administered once at baseline and once at follow-up. The ISI (Morin, 1993) was used to assess perceived sleep difficulties or current insomnia symptom severity (i.e., past two weeks). The ISI is a 7-item, self-report instrument with good reliability and validity, and positively correlated with clinician-rated insomnia diagnoses (Bastien, Vallières, \& Morin, 2001). Total scores on the full 7-item scale range from 0 - 28 with higher values representing greater sleep continuity disturbance or insomnia severity. The four different treatment groups will be compared for differences.
ISI is measured once at baseline and once at follow-up (8-10 weeks apart)
Number of Subjects Who Dropped Out
up to 8 weeks of active study
CBT-I with Armodafinil (active medication)
Cognitive Behavioral Therapy for Insomnia with Placebo medication
Cognitive Behavioral Therapy for Insomnia.
Active medication
Michael L Perlis, PhD
University of Pennsylvania
39 participants (actual enrollment reported by the registry).
First Submitted
September 9, 2015
First Posted
September 17, 2015
Study Start
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
Feasibility of Internet Group CBT-I for Gyn Oncology Patients
Cognitive-behavioral Therapy for Insomnia in School-aged Children
Medication (armodafinil) only, without CBTI.
Placebo only, without CBTI.
Placebo for Nuvigil (armodafinil)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 2015
Actual (reported)Study Completion
July 2015
Actual (reported)Last Updated
July 31, 2017
Results First Posted
July 31, 2017
Record last verified: 2017-06
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Source: ClinicalTrials.gov.
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