Clinical Trials

Cognitive Behavioral Therapy and Light Therapy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05337943
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Pennsylvania
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lea Ann A Matura, PhD
Principal Investigator Affiliation	University of Pennsylvania
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension, Insomnia, Fatigue

Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Experimental: 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.

No Intervention: Standard Care

Subjects will continue the care they routinely receive.

Interventions

Behavioral: - CBT-I

Weekly sessions with a therapist to improve sleep for 8 weeks.

Device: - Bright Light Therapy

Daily light therapy for 30 minutes for 8 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4217