Fibromyalgia Sleep A to ZZZ Study

Purpose

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

Condition

  • Fibromyalgia

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.
    Other names:
    • Re-Timer
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.
  • Behavioral: Sleep Stabilization
    All participants will be asked to follow a fixed sleep schedule.
No Intervention
Control Group, treatment as usual 		Participants will be asked to sleep as per usual.

Recruiting Locations

University of Michigan
Ann Arbor, Michigan 48105
Contact:
Helen Burgess
734-615-8303
bhelen@med.umich.edu

More Details

Status
Recruiting
Sponsor
University of Michigan

Study Contact

Helen Burgess
734-615-8303
bhelen@umich.edu

Detailed Description

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