Fibromyalgia Sleep A to ZZZ Study

Not Applicable

Recruiting

• Conditions: Fibromyalgia
• Interventions: Device: Light Therapy; Behavioral: Sleep Stabilization

• Registration Number: NCT06567886
• Lead Sponsor: University of Michigan

Brief Summary

This research study is testing whether changes in sleep timing and morning light therapy may have an impact on symptoms related to fibromyalgia.

Detailed Description

This study will test a consumer health light therapy device (Re-Timer)

Study Timeline

• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-20
• Study First Posted: 2024-08-23
• Study Start: 2024-09-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2029-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

1. Meets 2016 revised diagnostic criteria for fibromyalgia (FM)
2. Has access to video conferencing (including web cameras and audio) and a private space for the remote study visits.

Exclusion Criteria

1. Significant chronic disease
2. Severe hearing or memory problems
3. Pending medical leave applications at workplace
4. Current pregnancy, breastfeeding, or actively trying to get pregnant
5. Night work or travel outside the eastern time zone within 1 month of the study
6. Other research participation
7. Frequent number of special events during study period (weddings, concerts, exams, etc).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Light Therapy	Light Therapy	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.
Sleep Stabilization	Sleep Stabilization	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.

Primary Outcome Measures

Name	Time	Method
Change in Fibromyalgia Impact Questionnaire-Revised (FIQR) score	baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).	The FIQR is 21 questions. Each question has 11 boxes similar to a visual analog scale. Questions include the difficulty associated with various physical activities and the severity of symptoms. The score for the questions is on a scale from 0 - 100, where lower scores represented better functional status.

Secondary Outcome Measures

Name	Time	Method
Change in Brief Pain Inventory (BPI) score	baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).	The BPI consists of 11 questions and assesses for the presence of pain, pain intensity (i.e., worst, least, average, current) and functional interference from pain. A higher score indicates more pain.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States