NCT05170386

Brief Summary

Cognitive impairment and sleeping disturbance following stroke diagnosis are common symptoms that significantly affect the quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

December 10, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
2.3 years until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

December 10, 2021

Last Update Submit

January 11, 2025

Conditions

Keywords

Strokesleep disorderscognition

Outcome Measures

Primary Outcomes (2)

  • Epworth sleeping scale (ESS)

    The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. The questionnaire takes no more than 2 or 3 minutes to answer. It is available in many different languages.

    4 weeks

  • Pittsburgh sleep quality index ( PSQI)

    0 self-reported items Minimum score: o; Maximum score: 21 0-3 scoring for each of the 7 components Higher scores indicate worse sleep quality • 7 components/sub-scales: subjective sleep qualitv, sleep latenev, sleep duration. habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction

    4 weeks

Secondary Outcomes (1)

  • The Mini-Mental State Examination (MMSE)

    four weeks

Study Arms (2)

study group

EXPERIMENTAL

receive cognitive training combined with instructive conventional treatment for sleeping disorder

Other: Cognitive training TherapyOther: instructive conventional treatment

control group

EXPERIMENTAL

receive instructive conventional treatment for sleeping disorder

Other: instructive conventional treatment

Interventions

Cognitive training Therapy include: Writing the reminiscences • Solving a table• Writing a letter making a calendar and writing a note about the daily activities on it Facing patients' fears instead of avoiding them.Using role-playing to prepare for potentially problematic interactions with others.Learning to calm one's mind and relax one's body.

study group

instructive conventional treatment breathing relaxation exercise inform of diaphragmatic breathing Practice sleep hygiene such as keeping a regular sleep schedule. Get regular exercise. Minimize noise. Minimize light. Manage the temperature so that you're comfortable.

control groupstudy group

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • stroke onset at least 5 months prior to study enrolment
  • with sleeping disturbance
  • age will range from 40:55
  • upper extremity spasticity ranging from
  • according to Modified Ashowrth Scale.

You may not qualify if:

  • difficulty to communicate
  • other neurological conditions that cause sleeping disorders
  • severe depression or other psychiatric symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lama S Mahmoud

Al Jīzah, Select State, Egypt

Location

MeSH Terms

Conditions

StrokeSleep Wake Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: group A (20 patients): that will receive cognitive training combined with instructive conventional treatment for sleeping disorder, and group B (20 patients): that will receive instructive conventional treatment for sleeping disorder
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity

Study Record Dates

First Submitted

December 10, 2021

First Posted

December 28, 2021

Study Start

April 1, 2024

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations