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Behavioral Intervention

Sleep Stabilization + Light Therapy for Fibromyalgia

N/A

Recruiting

Led By Afton Hassett

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (visit 3, day 8) to post-treatment (visit 7, approximately day 36).

Awards & highlights

No Placebo-Only Group

Summary

"This trial is investigating if adjusting sleep patterns and using morning light therapy can help improve symptoms of fibromyalgia."

Who is the study for?

This trial is for individuals with fibromyalgia or myofascial pain syndrome who are interested in exploring how sleep stabilization and morning light therapy might affect their symptoms. Specific eligibility criteria details were not provided.

What is being tested?

The study is examining the effects of regulated sleep patterns and exposure to morning light therapy on fibromyalgia-related symptoms, aiming to understand if these interventions can provide relief.

What are the potential side effects?

Potential side effects may include discomfort from changes in sleep habits and sensitivity or eye strain due to light therapy, but specific side effect details were not provided.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (visit 3, day 8) to post-treatment (visit 7, approximately day 36).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (visit 3, day 8) to post-treatment (visit 7, approximately day 36).

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (visit 3, day 8) to post-treatment (visit 7, approximately day 36). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Fibromyalgia Impact Questionnaire-Revised (FIQR) score

Secondary study objectives

Change in Brief Pain Inventory (BPI) score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Sleep StabilizationExperimental Treatment1 Intervention

All participants will be asked to attend 8 virtual visits over 5 months. Participants randomized to the sleep stabilization arm are asked to follow a fixed sleep schedule tailored to their sleep during a baseline period. The treatment period is 4 weeks.

Group II: Light TherapyExperimental Treatment1 Intervention

All participants will be asked to attend 8 virtual visits over 5 months. Participants randomized to the morning light therapy group are asked to wear the glasses for 1 hour per day. The timing of each person's therapy is tailored to their average wake up time during a baseline period. The treatment period is 4 weeks long.

Group III: Control Group, treatment as usualActive Control1 Intervention

Participants will be asked to sleep as per usual.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Light Therapy

2002

Completed Phase 1

~320

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