Fibromyalgia Sleep A to ZZZ Study

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT06567886
Status
Recruiting
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Conditions

  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Light Therapy — 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 — BEHAVIORAL
    All participants will be asked to follow a fixed sleep schedule.

Study Details

This research study is testing whether changes in sleep timing and morning light therapy may have an impact on symptoms related to fibromyalgia.

Key Dates

Start date
Sep 27, 2024
Status verified
Jun 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
390 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48105
Helen Burgess
[email protected]
734-615-8303
Afton Hassett, PsyD (PRINCIPAL_INVESTIGATOR)
Helen Burgess, PhD (PRINCIPAL_INVESTIGATOR)

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