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

Effects of Blue-enriched White Light Therapy on Sleep Quality, Depression, Psychomotor Vigilance, and Symptom Severity in Patients With Fibromyalgia

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: light therapy

Detailed Description

Fibromyalgia is a central sensitivity syndrome characterized by chronic widespread pain, cognitive dysfunctions, fatigue, sleep disorders, and circadian dysregulation. 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, research into the effect of light therapy for patients with fibromyalgia who often suffer from sleep and mood disturbance, pain, and cognitive impairments is of both research interest and therapeutic implications. This study will use a randomized, parallel group, assessor-blind, waiting-list controlled trial design. The primary outcome is symptom severity. The secondary outcomes include: sleep quality; depressive symptoms; psychomotor vigilance and attention; and sleep phase changes. The intervention will take 8 weeks with 30 minutes exposure at awakening to blue-enriched white light. A total of 80 participants, aged 20 to 64, with a diagnosis of fibromyalgia will be enrolled and randomly assigned into one of the two parallel groups: an intervention and a waiting list group. For the intervention group, outcomes will be assessed at baseline, immediately after, and 2 months after the 8-week intervention period. For the waiting list group, outcomes will be assessed at baseline, immediately after the 8-week waiting period, and 2 months after the intervention period.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Bio-Behavior Research Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Subjects who are admitted to the hospital.
2. Subjects who have other significant chronic disease, past or present psychosis, or bipolar disorder.
3. 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.
4. Subjects who are taking opiates or benzodiazepines.
5. Subjects who work night shifts, or travel across more than two time zones in the month prior to enrolling in the study.
6. Subjects who are pregnant.
7. Subjects who have used light treatment in the last 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Light therapy group; The intervention will take 8 weeks with 30 minutes exposure at awakening to blue-enriched white light.	Other: light therapy; The intervention will take 8 weeks with 30 minutes exposure at awakening to blue-enriched white light.
No Intervention: Waiting list group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality	The Pittsburgh Sleep Quality Index (PSQI) is a self-administered questionnaire that assesses sleep quality over a 1-month time interval. The seven components include subjective sleep quality, sleep latency, total sleep time, habitual sleep efficiency, sleep disorders, use of sleep medications, and daytime dysfunction. All questions are scored on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where higher scores denote a poorer sleep quality.	Baseline
Sleep quality	The Pittsburgh Sleep Quality Index (PSQI) is a self-administered questionnaire that assesses sleep quality over a 1-month time interval. The seven components include subjective sleep quality, sleep latency, total sleep time, habitual sleep efficiency, sleep disorders, use of sleep medications, and daytime dysfunction. All questions are scored on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where higher scores denote a poorer sleep quality.	Immediately after the 8-week intervention period
Sleep quality	The Pittsburgh Sleep Quality Index (PSQI) is a self-administered questionnaire that assesses sleep quality over a 1-month time interval. The seven components include subjective sleep quality, sleep latency, total sleep time, habitual sleep efficiency, sleep disorders, use of sleep medications, and daytime dysfunction. All questions are scored on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where higher scores denote a poorer sleep quality.	2 months after the 8-week intervention period
Depressive symptoms	The Beck Depression Inventory Version 2 (BDI-II) is a self-report 21-item questionnaire in which responses are rated on a 0 to 3 interval scale, with a higher score denoting mire frequent symptoms. The possible score of BDI-II ranges from 0 to 63, with higher scores representing more sever ratings of depression.	Baseline
Depressive symptoms	The Beck Depression Inventory Version 2 (BDI-II) is a self-report 21-item questionnaire in which responses are rated on a 0 to 3 interval scale, with a higher score denoting mire frequent symptoms. The possible score of BDI-II ranges from 0 to 63, with higher scores representing more sever ratings of depression.	Immediately after the 8-week intervention period
Depressive symptoms	The Beck Depression Inventory Version 2 (BDI-II) is a self-report 21-item questionnaire in which responses are rated on a 0 to 3 interval scale, with a higher score denoting mire frequent symptoms. The possible score of BDI-II ranges from 0 to 63, with higher scores representing more sever ratings of depression.	2 months after the 8-week intervention period
Psychomotor vigilance and attention	Psychomotor vigilance and attention will be measured using the Psychomotor Vigilance Task (PVT). The visual stimulus and performance feedback are presented on the device.	Baseline
Psychomotor vigilance and attention	Psychomotor vigilance and attention will be measured using the Psychomotor Vigilance Task (PVT). The visual stimulus and performance feedback are presented on the device.	Immediately after the 8-week intervention period
Psychomotor vigilance and attention	Psychomotor vigilance and attention will be measured using the Psychomotor Vigilance Task (PVT). The visual stimulus and performance feedback are presented on the device.	2 months after the 8-week intervention period
Sleep phase assessment	The Morningness-Eveningness Questionnaire (MEQ) is used to estimate phase preferences in circadian rhythms based on participants' self-descriptions. timing. Questions evaluate the time that individuals get up and go to bed, self-reported preferred times for physical and mental activity, and also the individual's subjective alertness. MEQ scores can range from 16 to 86, with lower scores indicating eveningness or later circadian timing, and higher scores indicating morningness or earlier circadian timing.	Baseline
Sleep phase assessment	The Morningness-Eveningness Questionnaire (MEQ) is used to estimate phase preferences in circadian rhythms based on participants' self-descriptions. timing. Questions evaluate the time that individuals get up and go to bed, self-reported preferred times for physical and mental activity, and also the individual's subjective alertness. MEQ scores can range from 16 to 86, with lower scores indicating eveningness or later circadian timing, and higher scores indicating morningness or earlier circadian timing.	Immediately after the 8-week intervention period
Sleep phase assessment	The Morningness-Eveningness Questionnaire (MEQ) is used to estimate phase preferences in circadian rhythms based on participants' self-descriptions. timing. Questions evaluate the time that individuals get up and go to bed, self-reported preferred times for physical and mental activity, and also the individual's subjective alertness. MEQ scores can range from 16 to 86, with lower scores indicating eveningness or later circadian timing, and higher scores indicating morningness or earlier circadian timing.	2 months after the 8-week intervention period

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Study Chair: Pei-Shan Tsai, PhD, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2020
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Fibromyalgia; Sleep quality; Light therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: N202003152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No