Fibromyalgia Sleep A to ZZZ Study
At Home Morning Bright Light Treatment for Chronic Nociplastic Pain
2 other identifiers
interventional
390
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2024
CompletedFirst Posted
Study publicly available on registry
August 23, 2024
CompletedStudy Start
First participant enrolled
September 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
June 17, 2025
June 1, 2025
4.4 years
August 20, 2024
June 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Fibromyalgia Impact Questionnaire-Revised (FIQR) score
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 Outcomes (1)
Change in Brief Pain Inventory (BPI) score
baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).
Study Arms (3)
Light Therapy
EXPERIMENTALAll 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
EXPERIMENTALAll 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.
Control Group, treatment as usual
NO INTERVENTIONParticipants will be asked to sleep as per usual.
Interventions
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.
All participants will be asked to follow a fixed sleep schedule.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48105, United States
Related Publications (1)
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: 40880266DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Afton Hassett
University of Michigan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry, Medical School
Study Record Dates
First Submitted
August 20, 2024
First Posted
August 23, 2024
Study Start
September 27, 2024
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
March 1, 2029
Last Updated
June 17, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- From study completion and up to 7 years following publication.
- 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.
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.