Trial · NCT02552303
The Treatment of Insomnia Comorbid With Sleep Disordered Breathing Using Armodafinil and/or Cognitive Behavioral Therapy for Insomnia
NCT02552303, Not applicable, Completed, University of Pennsylvania; results first posted 2017-07-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Treatment of Insomnia Comorbid With Sleep Disordered Breathing Using Armodafinil and/or Cognitive Behavioral Therapy for Insomnia. Trials, record NCT02552303. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02552303
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Treatment of Insomnia Comorbid With Sleep Disordered Breathing Using Armodafinil and/or Cognitive Behavioral Therapy for Insomnia
- NCT number
- NCT02552303
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 39 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Sleep Apnea, Insomnia
- Interventions
- Cognitive Behavioral Therapy for Insomnia, Armodafinil, Placebo
- First posted
- 2015-09-17
- Last updated
- 2017-07-31
- Results first posted
- 2017-07-31
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change in Sleep Continuity From Baseline to Follow-up, as Measured by the Insomnia Severity Index (ISI). | 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. |
| Secondary | Number of Subjects Who Dropped Out | 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). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Change in Sleep Continuity From Baseline to Follow-up, as Measured by the Insomnia Severity Index (ISI). | ISI is measured once at baseline and once at follow-up (8-10 weeks apart) | units on a scale (ISI) | MEAN | |
| SECONDARY | Number of Subjects Who Dropped Out | up to 8 weeks of active study | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Change in Sleep Continuity From Baseline to Follow-up, as Measured by the Insomnia Severity Index (ISI). | CBT for Insomnia (CBTI) + Armodafinil | 13.0 | Standard Deviation 2.1 | units on a scale (ISI) | |
| The Change in Sleep Continuity From Baseline to Follow-up, as Measured by the Insomnia Severity Index (ISI). | CBTI + Placebo | 17.9 | Standard Deviation 0.2 | units on a scale (ISI) | |
| The Change in Sleep Continuity From Baseline to Follow-up, as Measured by the Insomnia Severity Index (ISI). | Armodafinil | 7.7 | Standard Deviation 0.5 | units on a scale (ISI) | |
| The Change in Sleep Continuity From Baseline to Follow-up, as Measured by the Insomnia Severity Index (ISI). | Placebo | 6 | Standard Deviation 1.8 | units on a scale (ISI) | |
| Number of Subjects Who Dropped Out | CBT for Insomnia (CBTI) + Armodafinil | 3 | Participants | ||
| Number of Subjects Who Dropped Out | CBTI + Placebo | 4 | Participants | ||
| Number of Subjects Who Dropped Out | Armodafinil | 2 | Participants | ||
| Number of Subjects Who Dropped Out | Placebo | 1 | Participants |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Allocation | STARTED | CBT for Insomnia (CBTI) + Armodafinil | 10 | |
| Allocation | STARTED | CBTI + Placebo | 10 | |
| Allocation | STARTED | Armodafinil | 8 | |
| Allocation | STARTED | Placebo | 11 | |
| Allocation | COMPLETED | CBT for Insomnia (CBTI) + Armodafinil | 7 | |
| Allocation | COMPLETED | CBTI + Placebo | 8 | |
| Allocation | COMPLETED | Armodafinil | 7 | |
| Allocation | COMPLETED | Placebo | 10 | |
| Allocation | NOT COMPLETED | CBT for Insomnia (CBTI) + Armodafinil | 3 | |
| Allocation | NOT COMPLETED | CBTI + Placebo | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CBT for Insomnia (CBTI) + Armodafinil | 0 | 10 |
| Total, all-cause mortality | CBTI + Placebo | 0 | 10 |
| Total, all-cause mortality | Armodafinil | 0 | 8 |
| Total, all-cause mortality | Placebo | 0 | 11 |
| Total, other adverse events | CBT for Insomnia (CBTI) + Armodafinil | 0 | 10 |
| Total, other adverse events | CBTI + Placebo | 0 | 10 |
| Total, other adverse events | Armodafinil | 0 | 8 |
| Total, other adverse events | Placebo | 0 | 11 |
| Total, serious adverse events | CBT for Insomnia (CBTI) + Armodafinil | 0 | 10 |
| Total, serious adverse events | CBTI + Placebo | 0 | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02552303
GET https://conductscience.org/api/trials/v1/NCT02552303/flow?page=2