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

Primary Purpose

Fibromyalgia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
light therapy
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Light therapy, Sleep quality, Depression

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bio-Behavior Research Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Light therapy group

Waiting list group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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'.
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'.
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'.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 6, 2020
Last Updated
October 18, 2023
Sponsor
Taipei Medical University
Collaborators
Ministry of Science and Technology, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT04504721
Brief Title
Effects of Blue-enriched White Light Therapy in Patients With Fibromyalgia
Official Title
Effects of Blue-enriched White Light Therapy on Sleep Quality, Depression, Psychomotor Vigilance, and Symptom Severity in Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 22, 2020 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
Collaborators
Ministry of Science and Technology, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Light therapy, Sleep quality, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Light therapy group
Arm Type
Experimental
Arm Description
The intervention will take 8 weeks with 30 minutes exposure at awakening to blue-enriched white light.
Arm Title
Waiting list group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
light therapy
Intervention Description
The intervention will take 8 weeks with 30 minutes exposure at awakening to blue-enriched white light.
Primary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire-Revised Version
Description
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'.
Time Frame
Baseline
Title
Fibromyalgia Impact Questionnaire-Revised Version
Description
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'.
Time Frame
Immediately after the 8-week intervention period
Title
Fibromyalgia Impact Questionnaire-Revised Version
Description
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'.
Time Frame
2 months after the 8-week intervention period
Secondary Outcome Measure Information:
Title
Sleep quality
Description
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.
Time Frame
Baseline
Title
Sleep quality
Description
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.
Time Frame
Immediately after the 8-week intervention period
Title
Sleep quality
Description
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.
Time Frame
2 months after the 8-week intervention period
Title
Depressive symptoms
Description
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.
Time Frame
Baseline
Title
Depressive symptoms
Description
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.
Time Frame
Immediately after the 8-week intervention period
Title
Depressive symptoms
Description
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.
Time Frame
2 months after the 8-week intervention period
Title
Psychomotor vigilance and attention
Description
Psychomotor vigilance and attention will be measured using the Psychomotor Vigilance Task (PVT). The visual stimulus and performance feedback are presented on the device.
Time Frame
Baseline
Title
Psychomotor vigilance and attention
Description
Psychomotor vigilance and attention will be measured using the Psychomotor Vigilance Task (PVT). The visual stimulus and performance feedback are presented on the device.
Time Frame
Immediately after the 8-week intervention period
Title
Psychomotor vigilance and attention
Description
Psychomotor vigilance and attention will be measured using the Psychomotor Vigilance Task (PVT). The visual stimulus and performance feedback are presented on the device.
Time Frame
2 months after the 8-week intervention period
Title
Sleep phase assessment
Description
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.
Time Frame
Baseline
Title
Sleep phase assessment
Description
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.
Time Frame
Immediately after the 8-week intervention period
Title
Sleep phase assessment
Description
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.
Time Frame
2 months after the 8-week intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Shan Tsai, PhD
Organizational Affiliation
Taipei Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Bio-Behavior Research Laboratory
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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