- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02552303
The Treatment of Insomnia Comorbid With Sleep Disordered Breathing Using Armodafinil and/or Cognitive Behavioral Therapy for Insomnia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rationale:
Insomnia and sleep disordered breathing are the most common sleep disorders and they tend to be highly comorbid. When they co-occur, not only is there an increase in cumulative morbidity, but it is likely that these two diseases interact to: promote overall greater illness severity; reduce treatment adherence; and diminish treatment efficacy. The results from the proposed project will provide valuable information on how co-treatment for these two disorders can promote improved sleep quantity, enhanced sleep quality, better compliance with Positive Airway Pressure (PAP) therapy, and better daytime functioning.
Background:
There is now substantial evidence that Cognitive Behavioral Therapy for Insomnia (CBT-I) is efficacious for Primary Insomnia (PI), that it is as potent as sedative hypnotic treatment, and better sustained over time. Further, there is now increasing evidence that CBT-I can be applied to insomnias that are co-morbid with medical and psychiatric disorders, and with equal efficacy. The evidence for an expanded indication, to date, has been for insomnia comorbid with depression, chronic pain, and cancer. Interestingly, there are very few studies on the efficacy of CBT-I in insomnia comorbid with other intrinsic sleep disorders, including in patients with Sleep Disordered Breathing (SDB). This is surprising given that insomnia frequently occurs comorbidly with SDB. It is estimated that 40-60% of patients with SDB also suffer from insomnia. The lack of data regarding the applicability of CBT-I to insomnia co-morbid with SDB is likely due to the concern that CBT-I will be difficult to tolerate in patients with insomnia co-morbid with SDB given the treatment's tendency to produce acute increases in fatigue, sleepiness, and transient reductions in attention and performance. Accordingly, the investigators of this study propose to conduct a randomized, controlled trial on the effects of Armodafinil alone and in combination with CBT-I in patients with Insomnia comorbid with SDB.
Note: The choice to evaluate Armodafinil as both a monotherapy and an adjuvant therapy to CBT-I for insomnia has a firm conceptual basis and is supported by preliminary data from our group. The choice to evaluate Armodafinil in patients with insomnia co-morbid with SDB is further supported by the existing indication for sleepiness in patients with SDB.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CBT for Insomnia (CBTI) + Armodafinil
CBT-I with Armodafinil (active medication)
|
Cognitive Behavioral Therapy for Insomnia.
Other Names:
Active medication
Other Names:
|
Placebo Comparator: CBTI + Placebo
Cognitive Behavioral Therapy for Insomnia with Placebo medication
|
Cognitive Behavioral Therapy for Insomnia.
Other Names:
Placebo for Nuvigil (armodafinil)
|
Active Comparator: Armodafinil
Medication (armodafinil) only, without CBTI.
|
Active medication
Other Names:
|
Placebo Comparator: Placebo
Placebo only, without CBTI.
|
Placebo for Nuvigil (armodafinil)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Change in Sleep Continuity From Baseline to Follow-up, as Measured by the Insomnia Severity Index (ISI).
Time Frame: ISI is measured once at baseline and once at follow-up (8-10 weeks apart)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Who Dropped Out
Time Frame: up to 8 weeks of active study
|
Drop-out rates will be calculated by the number of protocol weeks the subject completed before withdrawing from the study. Drop out rates for subjects taking active v. placebo study medication were compared. Withdrawal indicates subjects who were either lost-to-follow-up (LTFU), chose to withdraw (self-withdrawn), were withdrawn by the study's PI (withdrawn by the investigator). |
up to 8 weeks of active study
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Respiratory Tract Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Sleep Apnea Syndromes
- Sleep Initiation and Maintenance Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Central Nervous System Stimulants
- Wakefulness-Promoting Agents
- Modafinil
Other Study ID Numbers
- 817800
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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