Bright Light Therapy for Post-COVID-19 Fatigue

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05677932
Collaborator
(none)
36
2
15.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Bright light therapy
  • Device: Dim red light therapy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized placebo-controlled trialRandomized placebo-controlled trial
Masking:
Single (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.
Primary Purpose:
Treatment
Official Title:
Bright Light Therapy for Post-COVID-19 Fatigue
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bright light therapy

10,000lux bright light

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

Experimental: Placebo group

50 lux dim red light

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

Outcome Measures

Primary Outcome Measures

  1. Change of fatigue symptoms [at 2 weeks (at the end of treatment)]

    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

  1. Change of insomnia symptoms [at 2 weeks (at the end of treatment)]

    The change in the score of Insomnia Severity Index (ISI), which ranges from 0-28, higher score indicates higher severity of insomnia

  2. Change of depressive symptoms [at 2 weeks (at the end of treatment)]

    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

  3. Change of anxiety symptoms [at 2 weeks (at the end of treatment)]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joey WY Chan, Associate Professor (Clinical), Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05677932
Other Study ID Numbers:
  • 2022.359
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 10, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Joey WY Chan, Associate Professor (Clinical), Chinese University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2023