- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05677932
Bright Light Therapy for Post-COVID-19 Fatigue
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- The Chinese University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bright light therapy
10,000lux bright light
|
Exposure to bright light therapy for 30mins a day for two weeks
|
|
Experimental: Placebo group
50 lux dim red light
|
Exposure to 50lux dim red light therapy for 30mins a day for two weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of fatigue symptoms
Time Frame: 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
|
at 2 weeks (at the end of treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of insomnia symptoms
Time Frame: 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
|
at 2 weeks (at the end of treatment)
|
|
Change of depressive symptoms
Time Frame: 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
|
at 2 weeks (at the end of treatment)
|
|
Change of anxiety symptoms
Time Frame: 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
|
at 2 weeks (at the end of treatment)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Post-Infectious Disorders
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- COVID-19
- Post-Acute COVID-19 Syndrome
- Fatigue
- Therapeutics
- Phototherapy
- Ultraviolet Therapy
Other Study ID Numbers
- 2022.359
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post COVID-19 Condition
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Karolinska University HospitalKarolinska Institutet; The Swedish Research Council; Region Stockholm; Swedish... and other collaboratorsCompletedCOVID-19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post COVID Condition | Post-Acute COVID-19 SyndromeSweden
-
StemCyte, Inc.Not yet recruitingLong COVID | Post-COVID Syndrome | Post-COVID-19 Condition | Post-COVID Condition
-
Lawson Research Institute of St. Joseph'sCanadian Institutes of Health Research (CIHR); Western University, CanadaRecruitingFatigue | Post-COVID-19 Syndrome | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19 | Long-COVID | Post-COVID ConditionCanada
-
Eggensberger OHGBavarian Health and Food Safety Authority (LGL)RecruitingPost COVID-19 Condition | Post COVID-19 | Post COVID-19 Syndrome | Long COVID-19 Syndrome | Post COVID-19 Condition (PCC)Germany
-
StemCyte, Inc.AvailableLong COVID | Post-COVID Syndrome | Chronic Fatigue | Post-COVID-19 Condition | Fatigue Post Viral | Post-COVID Condition | Chronic Fatigue SymptomsUnited States
-
Medical University of ViennaRecruitingVagus Nerve Diseases | Post-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID ConditionAustria
-
Fundación FLS de Lucha Contra el Sida, las Enfermedades...PharmaMar; IrsiCaixaRecruitingLong COVID | Post COVID-19 Condition | Long COVID Syndrome | Persistent COVID-19 | Persistent COVID ConditionSpain
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker CochinCompleted
-
Amsterdam UMC, location VUmcZonMw: The Netherlands Organisation for Health Research and Development; Post...RecruitingLong COVID | Post COVID-19 Condition (PCC) | PASC Post Acute Sequelae of COVID 19Netherlands
Clinical Trials on Bright light therapy
-
Peking University Sixth HospitalBeijing HuiLongGuan Hospital; Yan'an Third People's HospitalRecruiting
-
Sunnybrook Health Sciences CentreCompletedMajor Depressive Disorder | Seasonal Affective Disorder | NeuroimagingCanada
-
Hospital Authority, Hong KongUnknown
-
VA Office of Research and DevelopmentRecruiting
-
Medical University of ViennaCompletedMyalgic Encephalomyelitis/Chronic Fatigue SyndromeAustria
-
M.D. Anderson Cancer CenterTerminatedAdvanced CancersUnited States
-
University of OuluOulu University Hospital; University of Eastern Finland; ODL Terveys Oy; Valkee OyUnknownSeasonal Affective DisorderFinland
-
Universidade da CoruñaCompletedDementia | Mood | BehaviorSpain
-
State University of New York at BuffaloOncology Nursing SocietyCompletedFatigue | Sleep Disturbance | Circadian DysregulationUnited States
-
Medical University of ViennaNational Bank of AustriaUnknownMultiple Sclerosis | FatigueAustria