Trial Outcomes & Findings for Management of Insomnia in Breast Cancer Patients (NCT NCT01011218)
NCT ID: NCT01011218
Last Updated: 2018-11-29
Results Overview
Insomnia Severity Index (ISI) survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows. * 0 to 7 No clinically significant insomnia * 8 to14 Subthreshold insomnia * 15 to 21 Clinical insomnia (moderate severity) * 22 to 28 Clinical insomnia (severe) ISI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean ISI score with standard deviation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
up to 32 Weeks
Results posted on
2018-11-29
Participant Flow
Participant milestones
| Measure |
BBT-I + Armodafinil
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
Armodafinil 150 mg/day by mouth.
BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
|
Behavioral Placebo + Armodafinil
Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil 150 mg/day by mouth.
Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
|
BBT-I Without Armodafinil
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
No pharmaceutical intervention.
BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
|
Behavioral Placebo Without Armodafinil
Control behavioral intervention is a sleep hygiene handout completed by participant.
No pharmaceutical intervention.
Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
26
|
26
|
|
Overall Study
COMPLETED
|
9
|
9
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Management of Insomnia in Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
BBT-I + Armodafinil
n=9 Participants
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
Armodafinil 150 mg/day by mouth.
BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
|
Behavioral Placebo + Armodafinil
n=9 Participants
Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil 150 mg/day by mouth.
Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
|
BBT-I Without Armodafinil
n=26 Participants
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
No pharmaceutical intervention.
BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
|
Behavioral Placebo Without Armodafinil
n=26 Participants
Control behavioral intervention is a sleep hygiene handout completed by participant.
No pharmaceutical intervention.
Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
51.5 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
50.1 years
STANDARD_DEVIATION 9.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
26 participants
n=5 Participants
|
26 participants
n=4 Participants
|
70 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 32 WeeksPopulation: After baseline, it was not uncommon for participants to not contribute data for every time point.
Insomnia Severity Index (ISI) survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows. * 0 to 7 No clinically significant insomnia * 8 to14 Subthreshold insomnia * 15 to 21 Clinical insomnia (moderate severity) * 22 to 28 Clinical insomnia (severe) ISI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean ISI score with standard deviation.
Outcome measures
| Measure |
BBT-I + Armodafinil
n=9 Participants
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
Armodafinil 150 mg/day by mouth.
BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
|
Behavioral Placebo + Armodafinil
n=9 Participants
Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil 150 mg/day by mouth.
Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
|
BBT-I Without Armodafinil
n=26 Participants
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
No pharmaceutical intervention.
BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
|
Behavioral Placebo Without Armodafinil
n=26 Participants
Control behavioral intervention is a sleep hygiene handout completed by participant.
No pharmaceutical intervention.
Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
|
|---|---|---|---|---|
|
Insomnia Severity Index (ISI)
Baseline
|
16.3 units on a scale
Standard Deviation 7.4
|
14.6 units on a scale
Standard Deviation 6.3
|
13.5 units on a scale
Standard Deviation 5.2
|
12.1 units on a scale
Standard Deviation 5.4
|
|
Insomnia Severity Index (ISI)
3 Weeks
|
13.0 units on a scale
Standard Deviation 7.1
|
10.8 units on a scale
Standard Deviation 6.5
|
11.4 units on a scale
Standard Deviation 7.1
|
12.3 units on a scale
Standard Deviation 4.9
|
|
Insomnia Severity Index (ISI)
6 Weeks
|
9 units on a scale
Standard Deviation 6.1
|
10 units on a scale
Standard Deviation 6.9
|
8.0 units on a scale
Standard Deviation 5.7
|
10.5 units on a scale
Standard Deviation 6.5
|
|
Insomnia Severity Index (ISI)
10 Weeks
|
6.0 units on a scale
Standard Deviation 3.6
|
8.3 units on a scale
Standard Deviation 5.6
|
7.8 units on a scale
Standard Deviation 4.5
|
10.6 units on a scale
Standard Deviation 6.2
|
|
Insomnia Severity Index (ISI)
32 Weeks
|
3.0 units on a scale
Standard Deviation NA
Cannot generate standard deviation on single value.
|
7.6 units on a scale
Standard Deviation 4.4
|
7.0 units on a scale
Standard Deviation 4.6
|
8.1 units on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: up to 32 WeeksPopulation: After baseline, it was not uncommon for participants to not contribute data for every time point.
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) survey questionnaire is a 13-question subset of the 41-question Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of FACIT-Fatigue scores is from 0 to 52. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue. The FACIT-Fatigue survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation.
Outcome measures
| Measure |
BBT-I + Armodafinil
n=9 Participants
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
Armodafinil 150 mg/day by mouth.
BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
|
Behavioral Placebo + Armodafinil
n=9 Participants
Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil 150 mg/day by mouth.
Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
|
BBT-I Without Armodafinil
n=26 Participants
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
No pharmaceutical intervention.
BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
|
Behavioral Placebo Without Armodafinil
n=26 Participants
Control behavioral intervention is a sleep hygiene handout completed by participant.
No pharmaceutical intervention.
Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
|
|---|---|---|---|---|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Baseline
|
27.2 units on a scale
Standard Deviation 27.3
|
29.1 units on a scale
Standard Deviation 8.2
|
29.1 units on a scale
Standard Deviation 12.2
|
30.3 units on a scale
Standard Deviation 11.5
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
3 Weeks
|
33.5 units on a scale
Standard Deviation 12.5
|
29.6 units on a scale
Standard Deviation 10.2
|
29.4 units on a scale
Standard Deviation 11.3
|
31.0 units on a scale
Standard Deviation 11.5
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
6 Weeks
|
32.5 units on a scale
Standard Deviation 10.6
|
33.7 units on a scale
Standard Deviation 11.4
|
33.1 units on a scale
Standard Deviation 12.4
|
34.2 units on a scale
Standard Deviation 11.7
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
10 Weeks
|
41.5 units on a scale
Standard Deviation 10.0
|
34.2 units on a scale
Standard Deviation 12.7
|
33.2 units on a scale
Standard Deviation 11.5
|
34.5 units on a scale
Standard Deviation 13.8
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
32 Weeks
|
51 units on a scale
Standard Deviation NA
Standard deviation cannot be generated from a single value.
|
35.8 units on a scale
Standard Deviation 4.32
|
37.9 units on a scale
Standard Deviation 11.9
|
35.9 units on a scale
Standard Deviation 10.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 32 WeeksPopulation: After baseline, it was not uncommon for participants to not contribute data for every time point.
The full Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) survey questionnaire is a 41-question survey, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of scores is from 0 to 164. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue. The FACIT-F survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation.
Outcome measures
| Measure |
BBT-I + Armodafinil
n=9 Participants
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
Armodafinil 150 mg/day by mouth.
BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
|
Behavioral Placebo + Armodafinil
n=9 Participants
Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil 150 mg/day by mouth.
Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
|
BBT-I Without Armodafinil
n=26 Participants
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
No pharmaceutical intervention.
BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
|
Behavioral Placebo Without Armodafinil
n=26 Participants
Control behavioral intervention is a sleep hygiene handout completed by participant.
No pharmaceutical intervention.
Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
|
|---|---|---|---|---|
|
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Baseline
|
99.3 units on a scale
Standard Deviation 32.0
|
101.2 units on a scale
Standard Deviation 21.6
|
100.0 units on a scale
Standard Deviation 26.2
|
103.0 units on a scale
Standard Deviation 24.4
|
|
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
3 Weeks
|
109.8 units on a scale
Standard Deviation 25.8
|
99.2 units on a scale
Standard Deviation 26.8
|
101.8 units on a scale
Standard Deviation 27.3
|
103.3 units on a scale
Standard Deviation 29.5
|
|
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
6 Weeks
|
110.8 units on a scale
Standard Deviation 24.1
|
106.3 units on a scale
Standard Deviation 25.8
|
106.4 units on a scale
Standard Deviation 31.6
|
108.1 units on a scale
Standard Deviation 26.6
|
|
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
10 Weeks
|
125.5 units on a scale
Standard Deviation 21.6
|
111.2 units on a scale
Standard Deviation 29.6
|
107.3 units on a scale
Standard Deviation 26.9
|
107.9 units on a scale
Standard Deviation 32.0
|
|
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
32 Weeks
|
155 units on a scale
Standard Deviation NA
Standard deviation cannot be generated from a single value.
|
118.2 units on a scale
Standard Deviation 11.9
|
118.1 units on a scale
Standard Deviation 29.2
|
116.4 units on a scale
Standard Deviation 23.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 32 WeeksPopulation: After baseline, it was not uncommon for participants to not contribute data for every time point.
The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers ("No fatigue" to "As bad as you can imagine"), scored from 0 to 10, with each patient's overall BFI score being the mean of the values from each question (overall range 0 to 10). Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater fatigue. The BFI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean of the overall BFI scores with standard deviation.
Outcome measures
| Measure |
BBT-I + Armodafinil
n=9 Participants
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
Armodafinil 150 mg/day by mouth.
BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
|
Behavioral Placebo + Armodafinil
n=9 Participants
Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil 150 mg/day by mouth.
Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
|
BBT-I Without Armodafinil
n=26 Participants
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
No pharmaceutical intervention.
BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
|
Behavioral Placebo Without Armodafinil
n=26 Participants
Control behavioral intervention is a sleep hygiene handout completed by participant.
No pharmaceutical intervention.
Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
|
|---|---|---|---|---|
|
Brief Fatigue Inventory (BFI)
Baseline
|
5.5 units on a scale
Standard Deviation 2.6
|
5.2 units on a scale
Standard Deviation 2.0
|
4.4 units on a scale
Standard Deviation 2.7
|
4.1 units on a scale
Standard Deviation 2.4
|
|
Brief Fatigue Inventory (BFI)
3 Weeks
|
2.8 units on a scale
Standard Deviation 1.9
|
4.2 units on a scale
Standard Deviation 2.5
|
4.4 units on a scale
Standard Deviation 2.8
|
4.0 units on a scale
Standard Deviation 2.5
|
|
Brief Fatigue Inventory (BFI)
6 Weeks
|
4.0 units on a scale
Standard Deviation 2.5
|
3.8 units on a scale
Standard Deviation 2.5
|
3.0 units on a scale
Standard Deviation 2.4
|
3.4 units on a scale
Standard Deviation 2.3
|
|
Brief Fatigue Inventory (BFI)
10 Weeks
|
2.5 units on a scale
Standard Deviation 2.2
|
3.1 units on a scale
Standard Deviation 2.2
|
3.1 units on a scale
Standard Deviation 2.2
|
3.4 units on a scale
Standard Deviation 2.6
|
|
Brief Fatigue Inventory (BFI)
32 Weeks
|
1.0 units on a scale
Standard Deviation NA
Standard deviation cannot be generated from a single value.
|
3.6 units on a scale
Standard Deviation 2.0
|
2.7 units on a scale
Standard Deviation 2.3
|
3.6 units on a scale
Standard Deviation 2.6
|
Adverse Events
BBT-I + Armodafinil
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Behavioral Placebo + Armodafinil
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
BBT-I Without Armodafinil
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Behavioral Placebo Without Armodafinil
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BBT-I + Armodafinil
n=9 participants at risk
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
Armodafinil 150 mg/day by mouth.
BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
|
Behavioral Placebo + Armodafinil
n=9 participants at risk
Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil 150 mg/day by mouth.
Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
|
BBT-I Without Armodafinil
n=26 participants at risk
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
No pharmaceutical intervention.
BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
|
Behavioral Placebo Without Armodafinil
n=26 participants at risk
Control behavioral intervention is a sleep hygiene handout completed by participant.
No pharmaceutical intervention.
Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain, bone
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/26
|
0.00%
0/26
|
|
General disorders
Death, not otherwise specified
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
Other adverse events
| Measure |
BBT-I + Armodafinil
n=9 participants at risk
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
Armodafinil 150 mg/day by mouth.
BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
|
Behavioral Placebo + Armodafinil
n=9 participants at risk
Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil 150 mg/day by mouth.
Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
|
BBT-I Without Armodafinil
n=26 participants at risk
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
No pharmaceutical intervention.
BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
|
Behavioral Placebo Without Armodafinil
n=26 participants at risk
Control behavioral intervention is a sleep hygiene handout completed by participant.
No pharmaceutical intervention.
Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
|
|---|---|---|---|---|
|
Cardiac disorders
Heart rate increased
|
0.00%
0/9
|
0.00%
0/9
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1
|
33.3%
3/9 • Number of events 3
|
0.00%
0/26
|
0.00%
0/26
|
|
Gastrointestinal disorders
Pain, abdominal
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
|
Gastrointestinal disorders
Stomach ache
|
0.00%
0/9
|
0.00%
0/9
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
|
General disorders
Fatigue
|
22.2%
2/9 • Number of events 2
|
0.00%
0/9
|
0.00%
0/26
|
0.00%
0/26
|
|
General disorders
Fever
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
|
General disorders
Influenza
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
|
General disorders
Pain
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/26
|
0.00%
0/26
|
|
Infections and infestations
Infection, breast
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
|
Infections and infestations
Infection, bronchial
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Infection, upper respiratory
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
0.00%
0/26
|
0.00%
0/26
|
|
Nervous system disorders
Pain, sinus
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
|
Nervous system disorders
Presyncope
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/26
|
0.00%
0/26
|
|
Nervous system disorders
Seizure
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9
|
0.00%
0/9
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
|
Psychiatric disorders
Insomnia
|
33.3%
3/9 • Number of events 3
|
0.00%
0/9
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
Additional Information
Oxana RG Palesh, MD, PhD; Assistant Professor of Psychiatry and Behavioral Sciences
Stanford University Medical Center
Phone: 650-725-7011
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place