Recruiting NCT06567886
Fibromyalgia Sleep A to ZZZ Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Light Therapy, Sleep Stabilization.
- Who it may be relevant to
- Registry conditions: Fibromyalgia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
At Home Morning Bright Light Treatment for Chronic Nociplastic Pain
Overview
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)
Interventions
- 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. - Behavioral Sleep Stabilization
All participants will be asked to follow a fixed sleep schedule.
Primary outcome measures
- Change in Fibromyalgia Impact Questionnaire-Revised (FIQR) score [Time frame: baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).]
Secondary outcome measures (1)
- Change in Brief Pain Inventory (BPI) score [Time frame: baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).]
Eligibility criteria
Inclusion criteria
- Meets 2016 revised diagnostic criteria for fibromyalgia (FM)
- Has access to video conferencing (including web cameras and audio) and a private space for the remote study visits.
Exclusion criteria
- Significant chronic disease
- Severe hearing or memory problems
- Pending medical leave applications at workplace
- Current pregnancy, breastfeeding, or actively trying to get pregnant
- Night work or travel outside the eastern time zone within 1 month of the study
- Other research participation
- Frequent number of special events during study period (weddings, concerts, exams, etc).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Publications
- Burgess HJ, Rodgers AA, McNeil KA, Mott J, Fejer A, Dereski T, Rizvydeen M, Sibille KT, Kim HM, Cofield C, Burns JW, Shaikh S, Hassett AL. At-Home Morning Bright Light Treatment for Chronic Nociplastic Pain: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2025 Oct 13;14:e75060. doi: 10.2196/75060. PMID 40880266
Identifiers
NCT: NCT06567886 · HUM00240590 · 1R01NR021025-01