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Completed

NCT Number: NCT06611488

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.

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Key information

Conditions

Sleep Quality Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Postural Stability Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

67 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Majmaah University

Al Majmaah, Riyadh/ Saudi Arabia, 12271, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No Intervention: Observational Cohort

Other

No Intervention as the study is bservational Cohort

Primary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Shaimaa Mohamed Ahmed Elsayeh

Other

Collaborators

  • Majmaah University

Registry information

Official study title

Effect of Sleep Disturbances on Postural Control in the Elderly Population

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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