Sleep DeprivationNCT05170191
Effect of Sleep Deprivation on Sensory Integration of Balance, Fall Risk and Postural Stability
An observational study of Sleep Deprivation, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Sleepiness caused by sleep deprivation may increase the risk of injuries and damages during physical activity. Individual data so far indicates worsening of postural stability and control with females exhibiting better static postural stability regardless of sleeping conditions in comparison to men. Read more about this study
- Who is it for?
- Ages 19 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Sleep Deprivation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Dec 2021to 30 May 2022
- 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 19 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy young adults aged 19-24 will be included in the study.
Who may be able to join
- Age 19 to 24
- Healthy young adults from Rawalpindi/Islamabad.
- Both males and females
- Participants should have normal sleep patterns without any signs or symptoms of insomnia or hypersomnia.
- Persons without any sleep disorders.
- Persons without any neurological disease.
Who cannot join
- Persons with sleep disorders such as hypersomnia, insomnia, parasomnia etc.
- Elderly population.
- Persons with any sort of neurological deficits.
- COVID positive and those with any suspected signs and symptoms of COVID-19.
- Alcoholics
- Pregnant females
Show all 11Show fewer
- A participant with the history of or active diagnosed conditions of any of the following, which renders individual's performance will be excluded:
- Neurological.
- Musculoskeletal.
- Cardiopulmonary.
- Any congenital disorder or limb deformities.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University Institute of Rehabilitation Sciences.
Islamabad, Federal, 46000
About this study
Sleepiness caused by sleep deprivation may increase the risk of injuries and damages during physical activity. Individual data so far indicates worsening of postural stability and control with females exhibiting better static postural stability regardless of sleeping conditions in comparison to men. However, the literature is deficient in terms of postural stability conditions with eyes open and eyes closed states, as well as fall risk and sensory integration of balance.
- Conditions
- Sleep Deprivation
- Being tested
- Sleep Deprivation
- Keywords
- sleep deprivation
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep DeprivationBehavioural
The participants will stay awake for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Sleep deprivation | Participant data will be acquired before and after 24 hours of sleep deprivation. Receives: Behavioral: Sleep Deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Stability Index
Postural stability Index will be measured via Biodex Balance System. A lower score represents better postural stability.
Measured: 24 hours
Fall Risk Score
Fall Risk Score will be measured via Biodex Balance System. A lower score represents better postural stability.
Measured: 24 hours
Clinical Test of Sensory Integration and Balance
Clinical Test of Sensory Integration and Balance will be measured via Biodex Balance System. A lower score represents better postural stability.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start30 Dec 2021 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170191
- Sponsor's protocol ID
- FUI/CTR/2021/8
- Status last verified
- Dec 2021
- First submitted
- 22 Dec 2021
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sleep Deprivation on Sensory Integration of Balance, Fall Risk and Postural Stability
- ClinicalTrials.gov ID
- NCT05170191
- Acronym / sponsor ID
- FUI/CTR/2021/8
- Conditions
- Sleep Deprivation
- Keywords
- sleep deprivation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 30 Dec 2021 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 27 Dec 2021 (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.
Sleepiness caused by sleep deprivation may increase the risk of injuries and damages during physical activity. Individual data so far indicates worsening of postural stability and control with females exhibiting better static postural stability regardless of sleeping conditions in comparison to men. However, the literature is deficient in terms of postural stability conditions with eyes open and eyes closed states, as well as fall risk and sensory integration of balance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep deprivation | – | Behavioral: Sleep DeprivationParticipant data will be acquired before and after 24 hours of sleep deprivation. |
Who may qualify
- Ages
- 19 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy young adults aged 19-24 will be included in the study.
Key inclusion criteria (6 listed)
- Age 19 to 24
- Healthy young adults from Rawalpindi/Islamabad.
- Both males and females
- Participants should have normal sleep patterns without any signs or symptoms of insomnia or hypersomnia.
- Persons without any sleep disorders.
Key exclusion criteria (11 listed)
- Persons with sleep disorders such as hypersomnia, insomnia, parasomnia etc.
- Elderly population.
- Persons with any sort of neurological deficits.
- COVID positive and those with any suspected signs and symptoms of COVID-19.
- Alcoholics
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 |
|---|---|---|
| Sleep DeprivationThe participants will stay awake for 24 hours. | Behavioural | Sleep deprivation |
Primary outcome
Postural Stability Index
Time frame: 24 hours
Postural stability Index will be measured via Biodex Balance System. A lower score represents better postural stability.
Fall Risk Score
Time frame: 24 hours
Fall Risk Score will be measured via Biodex Balance System. A lower score represents better postural stability.
Clinical Test of Sensory Integration and Balance
Time frame: 24 hours
Clinical Test of Sensory Integration and Balance will be measured via Biodex Balance System. A lower score represents better postural stability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Deprivation, run by Foundation University Islamabad at 1 site in Pakistan.
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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Dec 2021. 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 Pakistan. 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?
Results are not available in the source record.
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 Index (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2021.