Bright Light Therapy as Possible Treatment Option for MS-... | NCT04681586

Studies
Bright Light Therapy as Possible Treatment Option for MS-Fatigue

NCT04681586

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Dec 23, 2020Actual

Enrollment

36Estimated

Phase

Not Applicable

Conditions

Multiple Sclerosis
Fatigue

Interventions

bright light therapy
dim red light

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2019Actual

Primary Completion Date

Sep 2021Estimated

Completion Date

Jan 2022Estimated

First Submitted Date

Oct 20, 2020

First Submission Date that Met QC Criteria

Dec 19, 2020

First Posted Date

Dec 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2020

Last Update Posted Date

Dec 23, 2020Actual

Name	Class
National Bank of Austria	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to investigate the effect of a 2-week trial of bright light therapy (BLT, 10.000 lx) on fatigue in multiple sclerosis (MS) patients. In this randomised placebo-controlled trial, the effect of bright light therapy will be compared to dim red light. MS-fatigue is quantified by patients using a visual analogue scale (VAS) and activity levels, subjective and objective sleep parameters and daytime sleepiness are measured.

Detailed Description

Materials and methods:

visual analogue scale (4x/day for 6 weeks; measuring fatigue)
wrist actigraphy (6 weeks)
sleep diaries (6 weeks)
polysomnography (2x)
multiple sleep latency test (2x)
4 subtests of the TAP (Testbatterie zur Aufmerksamkeitsprüfung; Alertness, Vigilance, Go/No-Go, Split Attention)
questionnaires (Fatigue Severity Scale, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Beck Depression Inventory, Beck Anxiety Inventory, Modified Fatigue Impact Scale, Morningness-Eveningness Questionnaire)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bright white light	Experimental		Device: bright light therapy
Dim red light	Placebo Comparator		Device: dim red light

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bright light therapy	Device	using a bright light therapy device (10.000 lux) for 30min every morning for two weeks	Bright white light

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in fatigue levels	Improvement of MS-fatigue symptoms as measured with questionnaires (Fatigue Severity Scale; FSS, Modified Fatigue Impact Scale; MFIS and a visual analogue scale)	Day 1, Day 14, Day 30, Day 46
Change in fatigue levels	Improvement of MS-fatigue symptoms as measured with psychological testing (Testbatterie zur Aufmerksamkeitsprüfung; TAP)	Day 15, Day 31

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Change in nighttime sleep	Improvement in nighttime sleep as measured with polysomnography (PSG)	Day 14, Day 30
Change in daytime sleepiness	Improvement of sxcessive daytime sleepiness as measured using a multiple sleep latency test (MSLT) and Epworth Sleepiness Scale (ESS)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

MS patients who suffer from fatigue
Age between 18 and 65 years old
FSS Score of 36 or greater
ESS Score of 12 or greater
MEQ Score between 31 and 69
BDI Score lower than 19
BAI Score lower than 27
EDSS lower than 4

Exclusion Criteria:

sleep disorders (periodic limb movement disorders, obstructive or central sleep apnea, REM sleep behavior disorders)
change of antidepressive/fatigue influencing/sleep influencing/photosensizing/MS medication within the preceding 4 weeks
clinical MS-relapse within the preceding 4 weeks
consumption of alcohol: more than 1 glass per day
consumption of caffeine: more than 4 cups per day
current shift work
Jet lag (travelled across two or more time zones within 90 days before study screening
Retinopathy or other visual diseases/abnormalties
Traumatic brain injury within the preceding 5 years
pregnant or lactating
Participation in another clinical trial at the same time

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stefan Seidel, MD	Contact	0043 1 40 400 34280		stefan.seidel@meduniwien.ac.at
Lisa Voggenberger, MSc	Contact	0043 1 40 400 34280		lisa.voggenberger@meduniwien.ac.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna	Recruiting	Vienna		1090	Austria

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis
D005221	Fatigue

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D010789	Phototherapy
D013812	Therapeutics