Clinical trial NCT05677932: Bright Light Therapy for Post-COVID-19 Fatigue
Official title: Bright Light Therapy for Post-COVID-19 Fatigue
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post COVID-19 Condition
Keywords: COVID-19
Long COVID
Fatigue
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of fatigue symptoms
timeFrame: at 2 weeks (at the end of treatment)
Secondary outcomes:
measure: Change of insomnia symptoms
timeFrame: at 2 weeks (at the end of treatment)
measure: Change of depressive symptoms
timeFrame: at 2 weeks (at the end of treatment)
measure: Change of anxiety symptoms
timeFrame: at 2 weeks (at the end of treatment)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: