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Bright Light Therapy for Post-COVID-19 Fatigue

Primary Purpose

Post COVID-19 Condition

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Bright light therapy
Dim red light therapy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post COVID-19 Condition focused on measuring COVID-19, Long COVID, Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 or above Capable to give informed consent COVID-19 infection confirmed by PCR test or a Rapid Antigen Test (RAT) with onset of at least three months Reports new onset or exacerbation of fatigue after onset of COVID-19 and lasted for over two months Scoring 7 or above for the item "worst level of fatigue during the last 24 hours" in the Brief Fatigue Inventory Exclusion Criteria: A current or past history of bipolar disorder, schizophrenia, neurodevelopmental disorder, organic mental disorder; intellectual disabilities or substance use disorder. Presence of contraindications to bright light therapy: for example, history of light induced migraine/ epilepsy; current use of photosensitizing medications; presence of eye disease: e.g. retinal blindness, severe cataract, glaucoma. Significant medical condition/ hearing impairment/ speech deficit leading to incapability of completing clinical interview. Regular shift-workers Trans-meridian flight in the past 3 months and during the study Currently receiving any structured psychotherapy Self-reported untreated sleep disorders (e.g. severe insomnia, obstructive sleep apnea, restless leg syndrome), psychiatric illness (e.g. depression), or medical conditions associated with fatigue (e.g. anemia, heart failure, autoimmune disorders) Enrolment in another clinical trial of an investigational medicinal product or device.

Sites / Locations

  • The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bright light therapy

Placebo group

Arm Description

10,000lux bright light

50 lux dim red light

Outcomes

Primary Outcome Measures

Change of fatigue symptoms
Change in the score of the Brief Fatigue Inventory (BFI). BFI ranges from 0 to 90, higher scales indicates more severe fatigue

Secondary Outcome Measures

Change of insomnia symptoms
The change in the score of Insomnia Severity Index (ISI), which ranges from 0-28, higher score indicates higher severity of insomnia
Change of depressive symptoms
The change in the score of Patient Health Questionnaire -9 item (PHQ-9), which ranges from 0-27, with higher score indicates greater severity of depressive symptoms
Change of anxiety symptoms
The change in the score of Generalized Anxiety Disorder 7-item (GAD-7), which ranges from 0-21, with higher score indicates greater severity of anxiety symptoms

Full Information

First Posted
January 6, 2023
Last Updated
March 7, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05677932
Brief Title
Bright Light Therapy for Post-COVID-19 Fatigue
Official Title
Bright Light Therapy for Post-COVID-19 Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

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

5. Study Description

Brief Summary
This is a randomized placebo-controlled trial to examine the efficacy of two-week bright light therapy for patients with post-COVID-19 fatigue.
Detailed Description
This randomized placebo-controlled trial aims to evaluate the efficacy of BLT in reducing fatigue symptoms after COVID-19 infection. The second aim of the study is to explore the effects of BLT on insomnia, depression and anxiety symptoms. Method: Each eligible participant will be randomized to either i) bright light therapy (BLT) or ii) dim red light (placebo) treatment for 30-minutes daily at their habitual wake time for a total of two weeks. Participants will be evaluated at baseline, 2nd (end of treatment), and 4th week (post-treatment 2-week) for fatigue and other symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post COVID-19 Condition
Keywords
COVID-19, Long COVID, Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized placebo-controlled trial
Masking
Participant
Masking Description
The subjects will be explained that the study aims to test the efficacy of two different modalities of light treatments for fatigue including white light and red light, without mentioning which one is the placebo.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bright light therapy
Arm Type
Experimental
Arm Description
10,000lux bright light
Arm Title
Placebo group
Arm Type
Experimental
Arm Description
50 lux dim red light
Intervention Type
Device
Intervention Name(s)
Bright light therapy
Intervention Description
Exposure to bright light therapy for 30mins a day for two weeks
Intervention Type
Device
Intervention Name(s)
Dim red light therapy
Intervention Description
Exposure to 50lux dim red light therapy for 30mins a day for two weeks
Primary Outcome Measure Information:
Title
Change of fatigue symptoms
Description
Change in the score of the Brief Fatigue Inventory (BFI). BFI ranges from 0 to 90, higher scales indicates more severe fatigue
Time Frame
at 2 weeks (at the end of treatment)
Secondary Outcome Measure Information:
Title
Change of insomnia symptoms
Description
The change in the score of Insomnia Severity Index (ISI), which ranges from 0-28, higher score indicates higher severity of insomnia
Time Frame
at 2 weeks (at the end of treatment)
Title
Change of depressive symptoms
Description
The change in the score of Patient Health Questionnaire -9 item (PHQ-9), which ranges from 0-27, with higher score indicates greater severity of depressive symptoms
Time Frame
at 2 weeks (at the end of treatment)
Title
Change of anxiety symptoms
Description
The change in the score of Generalized Anxiety Disorder 7-item (GAD-7), which ranges from 0-21, with higher score indicates greater severity of anxiety symptoms
Time Frame
at 2 weeks (at the end of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or above Capable to give informed consent COVID-19 infection confirmed by PCR test or a Rapid Antigen Test (RAT) with onset of at least three months Reports new onset or exacerbation of fatigue after onset of COVID-19 and lasted for over two months Scoring 7 or above for the item "worst level of fatigue during the last 24 hours" in the Brief Fatigue Inventory Exclusion Criteria: A current or past history of bipolar disorder, schizophrenia, neurodevelopmental disorder, organic mental disorder; intellectual disabilities or substance use disorder. Presence of contraindications to bright light therapy: for example, history of light induced migraine/ epilepsy; current use of photosensitizing medications; presence of eye disease: e.g. retinal blindness, severe cataract, glaucoma. Significant medical condition/ hearing impairment/ speech deficit leading to incapability of completing clinical interview. Regular shift-workers Trans-meridian flight in the past 3 months and during the study Currently receiving any structured psychotherapy Self-reported untreated sleep disorders (e.g. severe insomnia, obstructive sleep apnea, restless leg syndrome), psychiatric illness (e.g. depression), or medical conditions associated with fatigue (e.g. anemia, heart failure, autoimmune disorders) Enrolment in another clinical trial of an investigational medicinal product or device.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joey WY Chan
Phone
+852 39197647
Email
joeywychan@cuhk.edu.hk
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joey WY Chan, FHKAM(Psych)
Phone
+862 39197647
Email
joeywychan@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Jessie Tsang
Phone
+852 39197792
Email
jessietsang@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No

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Bright Light Therapy for Post-COVID-19 Fatigue

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