Fibromyalgia Sleep A to ZZZ Study

June 2, 2026 updated by: Helen Burgess, University of Michigan

At Home Morning Bright Light Treatment for Chronic Nociplastic Pain

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

390

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Helen Burgess, PhD
        • Principal Investigator:
          • Afton Hassett, PsyD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Light Therapy

Participants will self-administer the daily light therapy within a few minutes of their assigned wake up time for one hour.

Researchers will provide a light log to note light on/off times, any interruptions to light therapy, and primary activity during light therapy.

Other Names:
  • Re-Timer
Experimental: 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.
Behavioral: Sleep Stabilization
All participants will be asked to follow a fixed sleep schedule.
No Intervention: Control Group, treatment as usual
Participants will be asked to sleep as per usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fibromyalgia Impact Questionnaire-Revised (FIQR) score
Time Frame: 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.
baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Brief Pain Inventory (BPI) score
Time Frame: 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.
baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Afton Hassett, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2024

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00240590
  • 1R01NR021025-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After the study is completed, the de-identified, archived data will be transmitted to and stored at the NHLBI National Sleep Research Resource (NSRR) data repository.

IPD Sharing Time Frame

From study completion and up to 7 years following publication.

IPD Sharing Access Criteria

Members of the scientific community who would like a copy of the final data sets (i.e., data sets underlying any publication) from this study can request a copy by contacting the principal investigators and/or NSRR.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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