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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04504721
• Other study ID #: N202003152
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 22, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: October 2023
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: July 31, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
Taiwan	Bio-Behavior Research Laboratory	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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