FibromyalgiaNCT06567886
Fibromyalgia Sleep A to ZZZ Study
A study testing Light Therapy and Sleep Stabilization in people with Fibromyalgia, run by University of Michigan at 1 site in United States.
Trial summary
This research study is testing whether changes in sleep timing and morning light therapy may have an impact on symptoms related to fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Light Therapy and Sleep Stabilization
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2024to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48105
Helen Burgess, 734-615-8303, bhelen@med.umich.edu
Afton Hassett, PsyD
About this study
Official title: 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.
Read the detailed description
This study will test a consumer health light therapy device (Re-Timer)
- Conditions
- Fibromyalgia
- Being tested
- Light Therapy, Sleep Stabilization
- Keywords
- Sleep timing stabilization, Morning light therapy
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light TherapyDevice
Also called Re-Timer
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 StabilizationBehavioural
All participants will be asked to follow a fixed sleep schedule.
| Study group | Role | What they receive |
|---|---|---|
| Light Therapy | Experimental | 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. Receives: Device: Light Therapy |
| Sleep Stabilization | Experimental | 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. Receives: Behavioral: Sleep Stabilization |
| Control Group, treatment as usual | No intervention | Participants will be asked to sleep as per usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).
Secondary outcomes (1)
Change in Brief Pain Inventory (BPI) score
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.
Measured: baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start27 Sep 2024
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Helen Burgess, University of Michigan
- Investigators
- Afton Hassett, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567886
- Sponsor's protocol ID
- HUM00240590
- Other IDs
- 1R01NR021025-01
- Status last verified
- Jun 2026
- First submitted
- 20 Aug 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 40880266
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At Home Morning Bright Light Treatment for Chronic Nociplastic Pain
- ClinicalTrials.gov ID
- NCT06567886
- Acronym / sponsor ID
- HUM00240590
- Conditions
- Fibromyalgia
- Keywords
- Sleep timing stabilization, Morning light therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Light Therapy | Experimental | Device: Light TherapyAll 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 | Experimental | Behavioral: Sleep StabilizationAll 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 intervention | –Participants will be asked to sleep as per usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light TherapyAlso: Re-TimerParticipants 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. | Device | Light Therapy |
| Sleep StabilizationAll participants will be asked to follow a fixed sleep schedule. | Behavioural | Sleep Stabilization |
Primary outcome
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.
1 secondary outcome
Change in Brief Pain Inventory (BPI) score
Time frame: baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Derived from this study: PubMed 40880266Burgess 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Afton Hassett principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light Therapy and Sleep Stabilization in people with Fibromyalgia, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helen Burgess (734-615-8303, bhelen@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06567886, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.