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

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Teva Pharmaceutical Industries, Ltd.
• Treatments: Armodafinil; Modafinil

Criteria

Inclusion Criteria:

• eligible subjects must have begun their CPAP treatment within the last 3 months

• current ESS (Sleepiness) Scores between 5-19

• no history of upper airway surgery (e.g. UPPP)

• able to understand written and spoken English

• able to swallow medication

• preferred sleep phase between 9:00 pm and 9:00 am

• willing to discontinue any sleep medications/over-the-counters(OTCs)/Herbals for insomnia for the 11-week study period.

• female participants must not be pregnant or breastfeeding and must agree to use two forms of birth control during the study period, as Armodafinil may interfere with hormonal birth control.

• all participants will be asked to postpone any additional or alternate treatments for their Obstructive Sleep Apnea (OSA) until after the completion of their participation in this research study.

• for other elective procedures, prospective participants are recommended to either postpone the procedure until after completion of their participation in this study, or alternatively to start the study after completion of the elective procedure.

Exclusion Criteria:

• CPAP usage exceeding three months prior to pre-screening

• suicide attempts within the last five years

• unstable medical or psychiatric illness

• cardiac abnormalities, liver, or kidney diseases

• sleep disorders other than insomnia or SDB

• evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence

• use of central nervous system (CNS) active medications, antidepressants and hypnotics prescribed as sleep-aids (these medications are permitted if prescribed for mediation of symptoms other than sleep and the patient has been on a stable dosage for a minimum of one month, with no anticipation of altering their dosage during the study period.)

• inadequate language comprehension

• pregnant or breastfeeding