Effects of Blue-enriched White Light Therapy in Patients with Fibromyalgia

NCT04504721 | Enrolling By Invitation

• 1 other identifier: N202003152
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Fibromyalgia is a chronic condition with an unclear etiology. The syndrome includes symptoms such as chronic musculoskeletal pain, cognitive dysfunctions, fatigue, sleep disorders, and circadian rhythm disturbances. Fibromyalgia-related pain is associated with a substantial socioeconomic burden including greater health care costs and productivity loss from work. Light therapy can improve sleep quality and sleep architecture, advance sleep phases and reduce pain sensitivity and that the effect of light therapy on mood and cognitive function have been widely supported.This randomized controlled study aims to examine the effects of light therapy on sleep quality, depressive symptoms, psychomotor vigilance performance, and overall symptom severity in patients with fibromyalgia.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Light therapy; Sleep quality; Depression

Outcome Measures

Primary Outcomes (3)

• Fibromyalgia Impact Questionnaire-Revised Version

  Fibromyalgia symptom severity will be measured using the Fibromyalgia Impact Questionnaire-Revised Version (FIQR) .The FIQR contains a total of 21 individual questions in three domains: function, impact and symptom domains. All questions are based on an 11-point numeric rating scale of 0 to 10, with '0' representing 'no difficulty' and '10' representing 'worst'.

  Baseline

• Fibromyalgia Impact Questionnaire-Revised Version

  Fibromyalgia symptom severity will be measured using the Fibromyalgia Impact Questionnaire-Revised Version (FIQR) .The FIQR contains a total of 21 individual questions in three domains: function, impact and symptom domains. All questions are based on an 11-point numeric rating scale of 0 to 10, with '0' representing 'no difficulty' and '10' representing 'worst'.

  Immediately after the 8-week intervention period

• Fibromyalgia Impact Questionnaire-Revised Version

  Fibromyalgia symptom severity will be measured using the Fibromyalgia Impact Questionnaire-Revised Version (FIQR) .The FIQR contains a total of 21 individual questions in three domains: function, impact and symptom domains. All questions are based on an 11-point numeric rating scale of 0 to 10, with '0' representing 'no difficulty' and '10' representing 'worst'.

  2 months after the 8-week intervention period

Secondary Outcomes (12)

• Sleep quality

  Baseline

• Sleep quality

  Immediately after the 8-week intervention period

• Sleep quality

  2 months after the 8-week intervention period

• Depressive symptoms

  Baseline

• Depressive symptoms

  Immediately after the 8-week intervention period

Study Arms (2)

Light therapy group

EXPERIMENTAL

The intervention will take 8 weeks with 30 minutes exposure at awakening to blue-enriched white light.

Other: light therapy

Waiting list group

NO INTERVENTION

Participants who are randomly assigned into the waiting list group will be told that they are on a waiting list to be enrolled in the study. Participants will be provided with light therapy after the first posttest outcome assessments are completed.

Interventions

light therapy OTHER

The intervention will take 8 weeks with 30 minutes exposure at awakening to blue-enriched white light.

Light therapy group

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be aged from 20 to 64 years old.
• Participants must read and understand Chinese language.
• Participants must be outpatients.
• Participants must have a confirmed diagnosis of fibromyalgia according to the 2016 American College of Rheumatology diagnostic criteria.

You may not qualify if:

• Subjects who are admitted to the hospital.
• Subjects who have other significant chronic disease, past or present psychosis, or bipolar disorder.
• Subjects who have ophthalmic pathology (cataract, macular degeneration, glaucoma, retinitis pigmentosa), eye surgery, diseases affecting the retina (retinopathy, diabetes, herpes, etc.), color blind, or taking photosensitizing medications.
• Subjects who are taking opiates or benzodiazepines.
• Subjects who work night shifts, or travel across more than two time zones in the month prior to enrolling in the study.
• Subjects who are pregnant.
• Subjects who have used light treatment in the last 6 months.

Sponsors & Collaborators

• Taipei Medical University: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Bio-Behavior Research Laboratory

Taipei, Taiwan

Location

MeSH Terms

Conditions

Fibromyalgia; Sleep Initiation and Maintenance Disorders; Depression

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Pei-Shan Tsai, PhD

  Taipei Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 7, 2020
• Study Start: May 22, 2020
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: February 24, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)