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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05170191
Other study ID # FUI/CTR/2021/8
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 30, 2021
Est. completion date May 30, 2022

Study information

Verified date December 2021
Source Foundation University Islamabad
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date May 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 24 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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 - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sleep Deprivation
The participants will stay awake for 24 hours.

Locations

Country Name City State
Pakistan Foundation University Institute of Rehabilitation Sciences. Islamabad Federal

Sponsors (1)

Lead Sponsor Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postural Stability Index Postural stability Index will be measured via Biodex Balance System. A lower score represents better postural stability. 24 hours
Primary Fall Risk Score Fall Risk Score will be measured via Biodex Balance System. A lower score represents better postural stability. 24 hours
Primary 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. 24 hours
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