NCT06012513

Brief Summary

  1. 1.To determine sleep disturbance in different types of multiple sclerosis.
  2. 2.To asses the effect of sleep disturbance on quality of life in patients with multiple sclerosis.
  3. 3.Correlation between sleep disturbance in different types of multiple sclerosis.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

July 27, 2023

Last Update Submit

August 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Identification of different types of sleep disorders in patients with multiple sclerosis

    Identification of different types of sleep disorders in patients with multiple sclerosis using different scales

    Baseline

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with Multiple Sclerosis according to McDonald Criteria 2017 attending the neurology outpatient clinic, Department of Neurology and Psychiatry,Assiut University

You may qualify if:

  • All patients fulfill the criteria of case definition of multiple sclerosis.
  • Gender: both sexes are included.
  • Willingness to participate in the study and to be subjected to the disease-related examinations and assessments.
  • Willing and able to provide informed consent.

You may not qualify if:

  • Patients unable to give informed consent.
  • Patients with history of psychiatric disorders or collagen disease such as Behcet's disease or other neurological or medical disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Tachibana N, Howard RS, Hirsch NP, Miller DH, Moseley IF, Fish D. Sleep problems in multiple sclerosis. Eur Neurol. 1994;34(6):320-3. doi: 10.1159/000117070.

    PMID: 7851452BACKGROUND
  • Merlino G, Fratticci L, Lenchig C, Valente M, Cargnelutti D, Picello M, Serafini A, Dolso P, Gigli GL. Prevalence of 'poor sleep' among patients with multiple sclerosis: an independent predictor of mental and physical status. Sleep Med. 2009 Jan;10(1):26-34. doi: 10.1016/j.sleep.2007.11.004. Epub 2008 Jan 22.

    PMID: 18207453BACKGROUND

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Mohammed Safwat Mahmoud Ahmed, Resident doctor

CONTACT

Tareq Ali Sayed Rageh, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 27, 2023

First Posted

August 25, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

August 25, 2023

Record last verified: 2023-08