Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635928
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Bright Light Therapy in MECFS Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessing Fatigue and Attention in Myalgic EncephalomyelitisChronic Fatigue Syndrome Patients Before and After Treatment With Bright Light Therapy a Prospective Randomized Controlled Crossover Study
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLTME
Brief Summary:
In this study patients with Myalgic EncephalomyelitisChronic Fatigue Syndrome MECFS will receive bright light therapy through portable lamps for 2 weeks They will either start with this treatment and then go through a wash-out period of two weeks followed by a wait period of two weeks or they will start with the wait period followed by a wash-out period followed by the treatment phase Patients are asked to fill out questionnaires rating their level of fatigue and they go through a standardized computer test assessing their attention levels both at multiple times throughout the study The aim of this study is to find out if treatment with bright light will improve subjective fatigue levels and objective attention levels inMECFS patients
Detailed Description:
Chronic Fatigue Syndrome CFS also referred to as Myalgic Encephalomyelitis ME is a chronic debilitating condition of unknown etiology Bright light therapy BLT has shown promising results in studies investigating its effect in patients with neurological disorders experiencing fatigue symptoms Mateen et al 2020 Sinclair et al 2014 West et al 2019 Since effective and low to no side effect therapies are duly needed for the treatment of MECFS we propose a randomized-controlled treatment approach with bright light therapy BLT
In this proposed study a total of 38 out-patients with a diagnosis of MECFS according to the criteria of the Institute of Medicine will be randomly assigned to a crossover design starting out either with BLT or being waitlisted for the course of two weeks Portable light boxes emitting full-spectrum visible light with a luminance intensity of 10000 lux measured at a distance of 50 cm will be used at the participants home for 2 weeks
Primary outcome of the study will be the level of fatigue before and after treatment as operationalized by the Chalder Fatigue Score Secondary outcomes include the objective activity pattern as measured by actigraphy as well as cognitive and metacognitive functioning assessed before and after treatment
In this proposed study a total of 38 out-patients with a diagnosis of MECFS according to the criteria of the Institute of Medicine will be randomly assigned to a crossover design starting out either with BLT or being waitlisted for the course of two weeks Portable light boxes emitting full-spectrum visible light with a luminance intensity of 10000 lux measured at a distance of 50 cm will be used at the participants home for 2 weeks
Primary outcome of the study will be the level of fatigue before and after treatment as operationalized by the Chalder Fatigue Score Secondary outcomes include the objective activity pattern as measured by actigraphy as well as cognitive and metacognitive functioning assessed before and after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None