Fatigue, Insomnia, Pulmonary Hypertension
Conditions
Brief summary
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.
Detailed description
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. * To assess the recruitment and retention rates of CBT-I and Bright Light Therapy. * To compare the effects of CBT-I and Bright Light Therapy to Standard of Care on (insomnia and fatigue severity) and secondary (wake after sleep onset and sleep onset latency) outcomes. * To test the effects of CBT-I and Bright Light Therapy to Standard of Care on the secondary outcome physical activity. * To test the effects of CBT-I and Bright Light Therapy to Standard of Care on the secondary outcomes: depression, dyspnea and QOL.
Interventions
BEHAVIORALCBT-I
Weekly sessions with a therapist to improve sleep for 8 weeks.
DEVICEBright Light Therapy
Daily light therapy for 30 minutes for 8 weeks.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PAH diagnosis * Insomnia * Fatigue
Exclusion criteria
* Untreated obstructive sleep apnea * Subjects with left-sided valvular disease * Hospitalized or acutely ill * Any eye disease such as, but not limited to, cataracts, glaucoma, retinal disorders (e.g. macular degeneration), or previous eye surgery * Subjects with photosensitivity (e.g. epilepsy) * Manic-depressive psychosis or Bipolar Disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate | 8 weeks | Number of participants who completed all study procedures. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Behavioral Therapy-Insomnia (CBT-I) 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.
CBT-I: Weekly sessions with a therapist to improve sleep for 8 weeks. | 1 |
| Bright Light Therapy 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.
Bright Light Therapy: Daily light therapy for 30 minutes for 8 weeks. | 3 |
| Standard Care Subjects will continue the care they routinely receive. | 2 |
| Total | 6 |
Baseline characteristics
| Characteristic | Bright Light Therapy | Total | Standard Care | Cognitive Behavioral Therapy-Insomnia (CBT-I) |
|---|---|---|---|---|
| Age, Continuous | 48.3 years STANDARD_DEVIATION 17.8 | 52.3 years STANDARD_DEVIATION 15.4 | 55.0 years STANDARD_DEVIATION 21.2 | 59.0 years STANDARD_DEVIATION 0 |
| Enrollment Arms | 3 Participants | 6 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 3 participants | 6 participants | 2 participants | 1 participants |
| Sex/Gender, Customized Female | 3 Participants | 6 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 3 | 0 / 2 |
| other Total, other adverse events | 0 / 1 | 0 / 3 | 0 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 3 | 0 / 2 |
Outcome results
Primary
Retention Rate
Number of participants who completed all study procedures.
Time frame: 8 weeks
Population: The participant randomized to CBT-I withdrew from the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cognitive Behavioral Therapy-Insomnia (CBT-I) | Retention Rate | 0 Participants |
| Bright Light Therapy | Retention Rate | 1 Participants |
| Standard Care | Retention Rate | 2 Participants |