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

NCT02552303 | Completed Results

• 1 other identifier: 817800
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sleep Apnea; Insomnia

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Number of Subjects Who Dropped Out

  up to 8 weeks of active study

Study Arms (4)

CBT for Insomnia (CBTI) + Armodafinil

ACTIVE COMPARATOR

CBT-I with Armodafinil (active medication)

Behavioral: Cognitive Behavioral Therapy for Insomnia; Drug: Armodafinil

CBTI + Placebo

PLACEBO COMPARATOR

Cognitive Behavioral Therapy for Insomnia with Placebo medication

Behavioral: Cognitive Behavioral Therapy for Insomnia; Drug: Placebo

Armodafinil

ACTIVE COMPARATOR

Medication (armodafinil) only, without CBTI.

Drug: Armodafinil

Placebo

PLACEBO COMPARATOR

Placebo only, without CBTI.

Drug: Placebo

Interventions

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia.

Also known as: CBT-I

CBT for Insomnia (CBTI) + Armodafinil; CBTI + Placebo

Armodafinil DRUG

Active medication

Also known as: NuVigil

Armodafinil; CBT for Insomnia (CBTI) + Armodafinil

Placebo DRUG

Placebo for Nuvigil (armodafinil)

CBTI + Placebo; Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Teva Pharmaceutical Industries, Ltd.: collaborator

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy; Modafinil

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Michael Perlis
• Organization: University of Pennsylvania

mperlis@upenn.edu

(215) 746-3577

Study Officials

• Michael L Perlis, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 17, 2015
• Study Start: April 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 31, 2017
• Results First Posted: July 31, 2017

Record last verified: 2017-06