N/A
N=6
Cognitive Behavioral Therapy and Light Therapy
Pulmonary Hypertension · Insomnia · Fatigue
Bottom Line
View on ClinicalTrials.gov: NCT05337943 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Retention Rate — 0; 1; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CBT-I (Behavioral); Bright Light Therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention Rate |
0; 1; 2 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT05337943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.