Sleep QualityNCT06611488
Sleep Disturbances on Postural Control in the Elderly Population
An observational study of Sleep Quality and Postural Stability, run by Shaimaa Mohamed Ahmed Elsayeh at 1 site in Saudi Arabia.
Trial 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 more about this study
- Who is it for?
- Ages 67 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Postural Stability
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Apr 2021to 1 Mar 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 67 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Elderly participant with age 67 years and more
Who may be able to join
- Be able to stand unsupported with eyes opened and eyes closed for 30 seconds.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
The Majmaah University
Al Majmaah, Riyadh/ Saudi Arabia, 12271
About this study
Official title: 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.
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.
- Conditions
- Sleep Quality, Postural Stability
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Sleep disturbances, Postural control, Elderly population
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No Intervention as the study is bservational Cohort
| Study group | Role | What they receive |
|---|---|---|
| Normal sleepiness group | Participants with normal daytime sleepiness Receives: Other: No Intervention: Observational Cohort | |
| Excessive daytime sleepiness group | Participants with excessive daytime sleepiness group Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "Immediately after enrollment"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Apr 2021
- Primary completion1 Jan 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Shaimaa Mohamed Ahmed Elsayeh
- Sponsor type
- University, hospital or other
- Collaborators
- Majmaah University
- Responsible party
- Sponsor-investigator, Shaimaa Mohamed Ahmed Elsayeh, Cairo University
- Investigators
- Abdulrhman Y Alqahtani, Master degree, Principal investigator, The Majmaah UniversityZeinab A Ali, PhD, Study director, Cairo UniversityShaimaa M Elsayeh, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611488
- Sponsor's protocol ID
- MUREC-March. I 7/COM -202 I /2
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sleep Disturbances on Postural Control in the Elderly Population
- ClinicalTrials.gov ID
- NCT06611488
- Acronym / sponsor ID
- MUREC-March. I 7/COM -202 I /2
- Conditions
- Sleep Quality, Postural Stability
- Keywords
- Sleep disturbances, Postural control, Elderly population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shaimaa Mohamed Ahmed ElsayehUniversity, hospital or other
- Collaborators
- Majmaah University
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal sleepiness group | – | Other: No Intervention: Observational CohortParticipants with normal daytime sleepiness |
| Excessive daytime sleepiness group | – | Other: No Intervention: Observational CohortParticipants with excessive daytime sleepiness group |
Who may qualify
- Ages
- 67 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Elderly participant with age 67 years and more
Key inclusion criteria (1 listed)
- Be able to stand unsupported with eyes opened and eyes closed for 30 seconds.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo Intervention as the study is bservational Cohort | Other | Excessive daytime sleepiness group, Normal sleepiness group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Background: PubMed 11408723Melzer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Quality and Postural Stability, run by Shaimaa Mohamed Ahmed Elsayeh at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural stability using STABLE platform (time frame: "Immediately after enrollment"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06611488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.