Sleep Disturbances on Postural Control in the Elderly Population

September 20, 2024 updated by: Shaimaa Mohamed Ahmed Elsayeh

Effect of Sleep Disturbances on Postural Control in the Elderly Population

The sleep disorders are common among older adults and comprises of wide spectrum of the sleep related issues like poor sleep quality, sleep deprivation and excessive day time sleepiness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Earlier studies were carried to determine the effect of sleep deprivation on the postural control parameters. The effect of poor sleep quality and excessive daytime sleepiness on the postural control were not widely studied. Aim : To determine the effect of the sleep quality and excessive daytime sleepiness on the postural stability during quiet standing and whether this influence vary based on the availability of the visual feedback.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Riyadh/ Saudi Arabia
      • Al Majmaah, Riyadh/ Saudi Arabia, Saudi Arabia, 12271
        • The Majmaah University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Elderly participant with age 67 years and more

Description

Inclusion Criteria:

  • Be able to stand unsupported with eyes opened and eyes closed for 30 seconds.

Exclusion Criteria:

  • Elderly with uncorrected visual impairment, Underwent bilateral hip replacement.
  • Participants using drugs which affect control.
  • Participants with previous history of conditions which affect postural control.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal sleepiness group
Participants with normal daytime sleepiness
Other: No Intervention: Observational Cohort
No Intervention as the study is bservational Cohort
Excessive daytime sleepiness group
Participants with excessive daytime sleepiness group
Other: No Intervention: Observational Cohort
No Intervention as the study is bservational Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postural stability using STABLE platform
Time Frame: "Immediately after enrollment"
The Postural stability of the participants was assessed using STABLE by Motek medical that made in Netherlands. During each trial, participants were made to stand quietly for 30 seconds on the platform of STABLE with open eyes first and after that with closed eyes "Individuals should initially complete two sessions of test with open eyes, then followed with closed eyes". And after that comparison of postural stability between both normal sleepiness and excessive daytime sleepiness groups.
"Immediately after enrollment"

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep parameters using the Arabic version of Pittsburgh Sleep Quality Index
Time Frame: "Immediately after enrollment"
The Arabic version of Pittsburgh Sleep Quality Index (PSQI), it's a self-administered validated questionnaire to ass the quality of sleep over previous weeks. The PSQI is comprehensive and consists of 19 items combined into seven subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications and daytime dysfunction. The scores of each component range from 0 to 3 and global or total PSQI score is calculated by summing all the scores of all seven components yielding a maximum possible score of 21. The higher scores reflecting poor sleep quality. In the current study, the cut-off score of more than 5 to categorize as poor sleep quality. It also will be used to align the participants to either normal sleepiness group or excessive day time sleepiness group.
"Immediately after enrollment"
Day time sleepiness using The Arabic version of Epworth Sleepiness Scale.
Time Frame: "Immediately after enrollment"
The Arabic version of Epworth Sleepiness Scale (ESS) was administered to determine the daytime sleepiness The ESS necessitates the user to report the chance of dozing as per four-point scale [0 indicates no chance of dosing, 1 indicates slight chance of dozing, 2 indicates moderate chance of dozing, 3 indicates high chance of dozing] in eight given situations. The scores of the ESS range from 0 to 24, higher scores demonstrating excessive daytime sleepiness. In the current study, the cut-off score of more than 10 to categorize as excessive daytime sleepiness. It will be used to align the participants to either normal sleepiness group or excessive day time sleepiness group.
"Immediately after enrollment"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaimaa Mohamed Ahmed Elsayeh

Collaborators

Majmaah University

Investigators

  • Principal Investigator: Abdulrhman Y Alqahtani, Master degree, The Majmaah University
  • Study Director: Zeinab A Ali, PhD, Cairo University
  • Study Director: Shaimaa M Elsayeh, PhD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

September 10, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 20, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUREC-March. I 7/COM -202 I /2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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