Trial Outcomes & Findings for The Treatment of Insomnia Comorbid With Sleep Disordered Breathing Using Armodafinil and/or Cognitive Behavioral Therapy for Insomnia (NCT NCT02552303)
NCT ID: NCT02552303
Last Updated: 2017-07-31
Results Overview
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.
COMPLETED
NA
39 participants
ISI is measured once at baseline and once at follow-up (8-10 weeks apart)
2017-07-31
Participant Flow
Participant milestones
| Measure |
CBT for Insomnia (CBTI) + Armodafinil
CBT-I with Armodafinil (active medication)
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Armodafinil: Active medication
|
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)
|
Armodafinil
Medication (armodafinil) only, without CBTI.
Armodafinil: Active medication
|
Placebo
Placebo only, without CBTI.
Placebo: Placebo for Nuvigil (armodafinil)
|
|---|---|---|---|---|
|
Allocation
STARTED
|
10
|
10
|
8
|
11
|
|
Allocation
COMPLETED
|
7
|
8
|
7
|
10
|
|
Allocation
NOT COMPLETED
|
3
|
2
|
1
|
1
|
|
Follow-Up
STARTED
|
7
|
8
|
7
|
10
|
|
Follow-Up
COMPLETED
|
7
|
6
|
6
|
10
|
|
Follow-Up
NOT COMPLETED
|
0
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
CBT for Insomnia (CBTI) + Armodafinil
CBT-I with Armodafinil (active medication)
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Armodafinil: Active medication
|
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)
|
Armodafinil
Medication (armodafinil) only, without CBTI.
Armodafinil: Active medication
|
Placebo
Placebo only, without CBTI.
Placebo: Placebo for Nuvigil (armodafinil)
|
|---|---|---|---|---|
|
Allocation
Withdrawal by Subject
|
2
|
1
|
1
|
1
|
|
Allocation
ineligible
|
1
|
1
|
0
|
0
|
|
Follow-Up
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Follow-Up
ineligible
|
0
|
2
|
0
|
0
|
Baseline Characteristics
The Treatment of Insomnia Comorbid With Sleep Disordered Breathing Using Armodafinil and/or Cognitive Behavioral Therapy for Insomnia
Baseline characteristics by cohort
| Measure |
CBT for Insomnia (CBTI) + Armodafinil
n=10 Participants
CBT-I with Armodafinil (active medication)
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Armodafinil: Active medication
|
CBTI + Placebo
n=10 Participants
Cognitive Behavioral Therapy for Insomnia with Placebo medication
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Placebo: Placebo for Nuvigil (armodafinil)
|
Armodafinil
n=8 Participants
Medication (armodafinil) only, without CBTI.
Armodafinil: Active medication
|
Placebo
n=11 Participants
Placebo only, without CBTI.
Placebo: Placebo for Nuvigil (armodafinil)
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
51.9 years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
48.2 years
STANDARD_DEVIATION 9.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
8 participants
n=5 Participants
|
11 participants
n=4 Participants
|
39 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
CBT for Insomnia (CBTI) + Armodafinil
n=7 Participants
CBT-I with Armodafinil (active medication)
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Armodafinil: Active medication
|
CBTI + Placebo
n=6 Participants
Cognitive Behavioral Therapy for Insomnia with Placebo medication
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Placebo: Placebo for Nuvigil (armodafinil)
|
Armodafinil
n=6 Participants
Medication (armodafinil) only, without CBTI.
Armodafinil: Active medication
|
Placebo
n=10 Participants
Placebo only, without CBTI.
Placebo: Placebo for Nuvigil (armodafinil)
|
|---|---|---|---|---|
|
The Change in Sleep Continuity From Baseline to Follow-up, as Measured by the Insomnia Severity Index (ISI).
|
13.0 units on a scale (ISI)
Standard Deviation 2.1
|
17.9 units on a scale (ISI)
Standard Deviation 0.2
|
7.7 units on a scale (ISI)
Standard Deviation 0.5
|
6 units on a scale (ISI)
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: up to 8 weeks of active studyDrop-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).
Outcome measures
| Measure |
CBT for Insomnia (CBTI) + Armodafinil
n=10 Participants
CBT-I with Armodafinil (active medication)
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Armodafinil: Active medication
|
CBTI + Placebo
n=10 Participants
Cognitive Behavioral Therapy for Insomnia with Placebo medication
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Placebo: Placebo for Nuvigil (armodafinil)
|
Armodafinil
n=8 Participants
Medication (armodafinil) only, without CBTI.
Armodafinil: Active medication
|
Placebo
n=11 Participants
Placebo only, without CBTI.
Placebo: Placebo for Nuvigil (armodafinil)
|
|---|---|---|---|---|
|
Number of Subjects Who Dropped Out
|
3 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
CBT for Insomnia (CBTI) + Armodafinil
CBTI + Placebo
Armodafinil
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place