Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Teva Pharmaceutical Industries, Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT for Insomnia (CBTI) + Armodafinil | Active Comparator | CBT-I with Armodafinil (active medication) |
|
| CBTI + Placebo | Placebo Comparator | Cognitive Behavioral Therapy for Insomnia with Placebo medication |
|
| Armodafinil | Active Comparator | Medication (armodafinil) only, without CBTI. |
|
| Placebo | Placebo Comparator | Placebo only, without CBTI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | Cognitive Behavioral Therapy for Insomnia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Dropped Out | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael L Perlis, PhD | University of Pennsylvania | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CBT for Insomnia (CBTI) + Armodafinil | CBT-I with Armodafinil (active medication) Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia. Armodafinil: Active medication |
| FG001 | CBTI + Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Allocation |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Armodafinil | Drug | Active medication |
|
|
| Placebo | Drug | Placebo for Nuvigil (armodafinil) |
|
| up to 8 weeks of active study |
Cognitive Behavioral Therapy for Insomnia with Placebo medication
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Placebo: Placebo for Nuvigil (armodafinil)
| FG002 | Armodafinil | Medication (armodafinil) only, without CBTI. Armodafinil: Active medication |
| FG003 | Placebo | Placebo only, without CBTI. Placebo: Placebo for Nuvigil (armodafinil) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-Up |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CBT for Insomnia (CBTI) + Armodafinil | CBT-I with Armodafinil (active medication) Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia. Armodafinil: Active medication |
| BG001 | CBTI + Placebo | Cognitive Behavioral Therapy for Insomnia with Placebo medication Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia. Placebo: Placebo for Nuvigil (armodafinil) |
| BG002 | Armodafinil | Medication (armodafinil) only, without CBTI. Armodafinil: Active medication |
| BG003 | Placebo | Placebo only, without CBTI. Placebo: Placebo for Nuvigil (armodafinil) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale (ISI) | ISI is measured once at baseline and once at follow-up (8-10 weeks apart) |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Who Dropped Out | 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). | Posted | Count of Participants | Participants | up to 8 weeks of active study |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBT for Insomnia (CBTI) + Armodafinil | CBT-I with Armodafinil (active medication) Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia. Armodafinil: Active medication | 0 | 10 | 0 | 10 | 0 | 10 |
| EG001 | CBTI + Placebo | Cognitive Behavioral Therapy for Insomnia with Placebo medication Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia. Placebo: Placebo for Nuvigil (armodafinil) | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Armodafinil | Medication (armodafinil) only, without CBTI. Armodafinil: Active medication | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | Placebo | Placebo only, without CBTI. Placebo: Placebo for Nuvigil (armodafinil) | 0 | 11 | 0 | 11 | 0 | 11 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Perlis | University of Pennsylvania | (215) 746-3577 | mperlis@upenn.edu |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| ineligible |
|
| Male |
|
Placebo only, without CBTI. Placebo: Placebo for Nuvigil (armodafinil) |
|
|