Fibromyalgia Sleep A to ZZZ Study

NCT ID: NCT06567886

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-27

Study Completion Date

2029-03-31

Brief Summary

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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

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

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Light Therapy

Intervention Type DEVICE

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 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.

Group Type EXPERIMENTAL

Sleep Stabilization

Intervention Type BEHAVIORAL

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

Control Group, treatment as usual

Participants will be asked to sleep as per usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Sleep Stabilization

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Re-Timer

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Helen Burgess

Professor of Psychiatry, Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Afton Hassett

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Helen Burgess

Role: CONTACT

734-615-8303

Facility Contacts

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Helen Burgess

Role: primary

734-615-8303

References

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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.

Reference Type DERIVED
PMID: 40880266 (View on PubMed)

Other Identifiers

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1R01NR021025-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00240590

Identifier Type: -

Identifier Source: org_study_id

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