NCT05170191

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

December 30, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

December 27, 2021

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

December 22, 2021

Last Update Submit

December 22, 2021

Conditions

Keywords

sleep deprivation

Outcome Measures

Primary Outcomes (3)

  • Postural Stability Index

    Postural stability Index will be measured via Biodex Balance System. A lower score represents better postural stability.

    24 hours

  • Fall Risk Score

    Fall Risk Score will be measured via Biodex Balance System. A lower score represents better postural stability.

    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.

    24 hours

Study Arms (1)

Sleep deprivation

Participant data will be acquired before and after 24 hours of sleep deprivation.

Behavioral: Sleep Deprivation

Interventions

The participants will stay awake for 24 hours.

Sleep deprivation

Eligibility Criteria

Age19 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy young adults aged 19-24 will be included in the study.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Institute of Rehabilitation Sciences.

Islamabad, Federal, 46000, Pakistan

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2021

First Posted

December 27, 2021

Study Start

December 30, 2021

Primary Completion

May 30, 2022

Study Completion

May 30, 2022

Last Updated

December 27, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations