Bright Light Therapy for Post-COVID-19 Fatigue

NCT ID: NCT05677932

Last Updated: 2023-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2024-04-30

Brief Summary

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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

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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.

Conditions

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Post COVID-19 Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized placebo-controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Bright light therapy

10,000lux bright light

Group Type EXPERIMENTAL

Bright light therapy

Intervention Type DEVICE

Exposure to bright light therapy for 30mins a day for two weeks

Placebo group

50 lux dim red light

Group Type EXPERIMENTAL

Dim red light therapy

Intervention Type DEVICE

Exposure to 50lux dim red light therapy for 30mins a day for two weeks

Interventions

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Bright light therapy

Exposure to bright light therapy for 30mins a day for two weeks

Intervention Type DEVICE

Dim red light therapy

Exposure to 50lux dim red light therapy for 30mins a day for two weeks

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Joey WY Chan

Associate Professor (Clinical)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Joey WY Chan

Role: CONTACT

+852 39197647

Facility Contacts

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Joey WY Chan, FHKAM(Psych)

Role: primary

+862 39197647

Jessie Tsang

Role: backup

+852 39197792

Other Identifiers

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2022.359

Identifier Type: -

Identifier Source: org_study_id

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