Bright Light Therapy for Post-COVID-19 Fatigue

NCT05677932 | Completed

• 1 other identifier: 2022.359
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Post COVID-19 Condition

Keywords

COVID-19; Long COVID; Fatigue

Outcome Measures

Primary Outcomes (1)

• 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

  at 2 weeks (at the end of treatment)

Secondary Outcomes (3)

• Change of insomnia symptoms

  at 2 weeks (at the end of treatment)

• Change of depressive symptoms

  at 2 weeks (at the end of treatment)

• Change of anxiety symptoms

  at 2 weeks (at the end of treatment)

Study Arms (2)

Bright light therapy

EXPERIMENTAL

10,000lux bright light

Device: Bright light therapy

Placebo group

EXPERIMENTAL

50 lux dim red light

Device: Dim red light therapy

Interventions

Bright light therapy DEVICE

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

Bright light therapy

Dim red light therapy DEVICE

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

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome; Fatigue

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Clinical)

Model Details: Randomized placebo-controlled trial

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 10, 2023
• Study Start: February 15, 2023
• Primary Completion: February 28, 2024
• Study Completion: April 30, 2024
• Last Updated: March 20, 2026

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)