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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shaimaa Mohamed Ahmed Elsayeh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Majmaah University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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