NCT06611488

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

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

Study Start

First participant enrolled

April 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

9 months

First QC Date

September 10, 2024

Last Update Submit

September 20, 2024

Conditions

Keywords

Sleep disturbancesPostural controlElderly population

Outcome Measures

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.

    "Immediately after enrollment"

Other Outcomes (2)

  • Sleep parameters using the Arabic version of Pittsburgh Sleep Quality Index

    "Immediately after enrollment"

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

    "Immediately after enrollment"

Study Arms (2)

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

No Intervention as the study is bservational Cohort

Excessive daytime sleepiness groupNormal sleepiness group

Eligibility Criteria

Age67 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Elderly participant with age 67 years and more

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Majmaah University

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

Location

Related Publications (1)

  • 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.

    PMID: 11408723BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersParasomnias

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Abdulrhman Y Alqahtani, Master degree

    The Majmaah University

    PRINCIPAL INVESTIGATOR
  • Zeinab A Ali, PhD

    Cairo University

    STUDY DIRECTOR
  • Shaimaa M Elsayeh, PhD

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 10, 2024

First Posted

September 25, 2024

Study Start

April 1, 2021

Primary Completion

January 1, 2022

Study Completion

March 1, 2022

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations