Recruiting

Fibromyalgia

Sponsor:

University of Michigan

Code:

NCT06567886

Conditions

Fibromyalgia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Light Therapy

Sleep Stabilization

Study Details

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.

Conditions

Fibromyalgia

Study ID

NCT06567886

Start date

Sep 27, 2024

Status verified date

Jun, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

390 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

no intervention: Control Group, treatment as usual

Participants will be asked to sleep as per usual.

Interventions

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.

Sleep Stabilization

All participants will be asked to follow a fixed sleep schedule.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Helen Burgess

734-615-8303bhelen@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

Helen Burgess

734-615-8303bhelen@med.umich.edu

Principal Investigator:

Afton Hassett, PsyD

More Information

Sponsor

University of Michigan

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • Sleep timing stabilization
  • Morning light therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-17. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-06-04.