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CompletedNCT06611488Updated Sep 25, 2024

Sleep Disturbances on Postural Control in the Elderly Population

An observational study in Sleep Quality and Postural Stability, sponsored by Shaimaa Mohamed Ahmed Elsayeh. Completed at 1 site in Saudi Arabia. Open to participants aged 67 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-25.

Sponsored by Shaimaa Mohamed Ahmed Elsayeh · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
30
Ages
67 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Sleep Quality
  • Postural Stability

Keywords

  • Sleep disturbances
  • Postural control
  • Elderly population
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In context

Dyssomnias

324 studies on the registry are indexed under Dyssomnias; 51 are open to participants now.

This study's enrollment of 30 is below the median of 126 across 63 observational studies indexed under Dyssomnias.

Browse Dyssomnias studies →

Lead sponsor

Shaimaa Mohamed Ahmed Elsayeh is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
67 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Elderly participant with age 67 years and more

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
30 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Normal sleepiness group

    Participants with normal daytime sleepiness

    Other: No Intervention: Observational Cohort

  • Excessive daytime sleepiness group

    Participants with excessive daytime sleepiness group

    Other: No Intervention: Observational Cohort

Interventions

  • OtherNo Intervention: Observational Cohort

    No Intervention as the study is bservational Cohort

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What researchers measure

Primary outcomes

  1. Postural stability using STABLE platform

    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.

    Time frame: "Immediately after enrollment"

Other outcomes

  1. Sleep parameters using the Arabic version of Pittsburgh Sleep Quality Index

    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.

    Time frame: "Immediately after enrollment"

  2. Day time sleepiness using The Arabic version of Epworth Sleepiness Scale.

    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.

    Time frame: "Immediately after enrollment"

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Study locations

1 site
  • The Majmaah University
    Al Majmaah, Riyadh/ Saudi Arabia 12271, Saudi Arabia
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References and documents

Publications

  • Melzer I, Benjuya N, Kaplanski J. Age-related changes of postural control: effect of cognitive tasks. Gerontology. 2001 Jul-Aug;47(4):189-94. doi: 10.1159/000052797. PubMed 11408723 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06611488
Lead sponsor
Shaimaa Mohamed Ahmed Elsayeh
Collaborators
Majmaah University
Responsible party
Shaimaa Mohamed Ahmed Elsayeh (Assistant Professor, Cairo University) — Sponsor-investigator
First posted
Sep 25, 2024
Start date
Apr 1, 2021
Primary completion
Jan 1, 2022
Completion
Mar 1, 2022
Last update
Sep 25, 2024

Study contacts

Abdulrhman Y Alqahtani, Master degree
principal investigator · The Majmaah University
Zeinab A Ali, PhD
study director · Cairo University
Shaimaa M Elsayeh, PhD
study director · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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