Fibromyalgia Sleep A to ZZZ Study

University of Michigan

Status: Enrolling

Conditions: Fibromyalgia

Treatments: Device: Light Therapy; Behavioral: Sleep Stabilization

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06567886

1R01NR021025-01 (U.S. NIH Grant/Contract)

HUM00240590

Details and patient eligibility

About

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

Full description

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

Enrollment: 390 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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390 participants in 3 patient groups

Light Therapy

Experimental group

Description:

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.

Treatment:

Device: Light Therapy

Sleep Stabilization

Experimental group

Description:

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.

Treatment:

Behavioral: Sleep Stabilization

Control Group, treatment as usual

No Intervention group

Description:

Participants will be asked to sleep as per usual.