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Cognitive Behavioral Therapy + Light Therapy for Insomnia

N/A
Waitlist Available
Led By Lea Ann A Matura, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PAH diagnosis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trialcompares the effectiveness of CBT-I and Bright Light Therapy for treating insomnia and fatigue in people with Pulmonary Arterial Hypertension.

Who is the study for?
This trial is for individuals with Pulmonary Arterial Hypertension (PAH) who are experiencing insomnia and fatigue. Candidates should not have untreated sleep apnea, heart valve disease, serious eye conditions, a history of photosensitivity disorders like epilepsy, or bipolar disorder.Check my eligibility
What is being tested?
The study compares the effectiveness of Bright Light Therapy versus Cognitive Behavioral Therapy for Insomnia (CBT-I) in treating insomnia and fatigue in PAH patients. The goal is to see if light therapy can improve both sleep and daytime energy levels.See study design
What are the potential side effects?
Bright Light Therapy may cause eyestrain, headache, nausea or agitation. CBT-I generally has no side effects but adjusting sleep habits can temporarily increase tiredness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with pulmonary arterial hypertension.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Retention Rate

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Behavioral Therapy-Insomnia (CBT-I)Experimental Treatment1 Intervention
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.
Group II: Bright Light TherapyExperimental Treatment1 Intervention
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.
Group III: Standard CareActive Control1 Intervention
Subjects will continue the care they routinely receive.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bright Light Therapy
2010
Completed Early Phase 1
~60
CBT-I
2018
Completed Phase 2
~620

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,052 Total Patients Enrolled
15 Trials studying Insomnia
4,580 Patients Enrolled for Insomnia
Lea Ann A Matura, PhDPrincipal InvestigatorUniversity of Pennsylvania

Media Library

Insomnia Clinical Trial 2023: Bright Light Therapy Highlights & Side Effects. Trial Name: NCT05337943 — N/A
Insomnia Patient Testimony for trial: Trial Name: NCT05337943 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there current openings for enrolment in this medical experiment?

"Affirmative. Data sourced from clinicaltrials.gov indicates that this medical trial, which was introduced on December 1st 2023, is actively seeking 36 individuals at a single location."

Answered by AI

How many people have been enlisted in this clinical experiment?

"Affirmative, the information on clinicaltrials.gov confirms that this study is still open for recruitment and actively seeking enrolment from participants. It was first posted in December 1st 2023 and has been updated as recently as January 19th 2023. 36 patients are needed at a single location to complete the trial."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

Because I suffer from Insomnia and Hypertension.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Cognitive Behavioral Therapy and Light Therapy
2023. "Cognitive Behavioral Therapy and Light Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05337943.
All > Sleep Disorders > Pulmonary Hypertension
~2 spots leftby May 2024
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