An interventional study of CBT-I and Bright Light Therapy in Pulmonary Hypertension, Insomnia and Fatigue, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
Cognitive behavioral therapy (CBT-I) is a common treatment for insomnia that does not use medications. While CBT-I is effective for insomnia, it does not tend to improve the waking symptom of fatigue. Another treatment, Bright Light Therapy, is used for treating seasonal depression and sleep disorders, and may improve fatigue and physical activity in individuals with PAH. The purpose of this study to assess the effects of Bright Light Therapy compared to CBT-I to treat insomnia and fatigue in patients with PAH.
In a single site, 3-arm (Cognitive Behavioral Therapy [CBT-I] group; Bright Light Therapy group; Standard of Care group), parallel, randomized controlled trial we will enroll 36 subjects (n=12 per group) to assess the feasibility of Bright Light Therapy compared to CBT-I in subjects with pulmonary arterial hypertension (PAH) to treat insomnia (difficulty initiating sleep or maintaining sleep) and fatigue.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's enrollment of 6 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CBT-I treatment will receive 1 session every week, for 8 weeks (8 total sessions). The CBT-I sessions will be provided by a pool of clinical PhD psychology students by a trained professional. Each visit will be conducted via telehealth. Sessions will include discussions regarding such topics as sleep restriction, stimulus control and sleep hygiene. Review of sleep diaries will occur during the sessions.
Behavioral: CBT-I
Bright Light treatment will consist of 8 weeks of daily use of the Re-timer device. The Re-timer is worn like a pair of glasses and contains light emitting diodes mounted on the lower portion of the frame. The Re-timer emits blue-green 500 nm light with an intensity of \~500 lux lm/m2. Subjects will be instructed to use the device for 30 minutes within two hours of waking, in the morning on the full brightness setting.
Device: Bright Light Therapy
Subjects will continue the care they routinely receive.
Weekly sessions with a therapist to improve sleep for 8 weeks.
Daily light therapy for 30 minutes for 8 weeks.
Retention Rate
Number of participants who completed all study procedures.
Time frame: 8 weeks
| Milestone | Cognitive Behavioral Therapy-Insomnia (CBT-I) | Bright Light Therapy | Standard Care |
|---|---|---|---|
| Started | 1 | 3 | 2 |
| Completed | 0 | 1 | 2 |
| Not completed | 1 | 2 | 0 |
Number of participants who completed all study procedures.
| Participants | Cognitive Behavioral Therapy-Insomnia (CBT-I) | Bright Light Therapy | Standard Care |
|---|---|---|---|
| Retention Rate | 0 | 1 | 2 |
Collected over 9 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cognitive Behavioral Therapy-Insomnia (CBT-I) | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Bright Light Therapy | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Standard Care | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Continuous(years) | Cognitive Behavioral Therapy-Insomnia (CBT-I) | Bright Light Therapy | Standard Care | Total |
|---|---|---|---|---|
| Mean | 59.0 ± 0 | 48.3 ± 17.8 | 55.0 ± 21.2 | 52.3 ± 15.4 |
| Sex/Gender, Customized(Participants) | Cognitive Behavioral Therapy-Insomnia (CBT-I) | Bright Light Therapy | Standard Care | Total |
|---|---|---|---|---|
| Female | 1 | 3 | 2 | 6 |
| Race (NIH/OMB)(Participants) | Cognitive Behavioral Therapy-Insomnia (CBT-I) | Bright Light Therapy | Standard Care | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 1 |
| White | 1 | 2 | 1 | 4 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cognitive Behavioral Therapy-Insomnia (CBT-I) | Bright Light Therapy | Standard Care | Total |
|---|---|---|---|---|
| United States | 1 | 3 | 2 | 6 |
| Enrollment Arms(Participants) | Cognitive Behavioral Therapy-Insomnia (CBT-I) | Bright Light Therapy | Standard Care | Total |
|---|---|---|---|---|
| Count of participants | 1 | 3 | 2 | 6 |
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