Healthy AdultsNCT04845464
Sleep Quality and Cognition in Young Adults
An observational study of Healthy Adults, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Sleep quality is impaired in young adults due to current conditions. Recent studies emphasize that this situation may also affect the cognitive status of individuals. The aim of this study was to investigate the relationship between sleep quality and cognitive status in young adults. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Cognitive Assessment (not diagnostic)
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Mar 2019to 21 Jan 2020
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults aged between 18 to 25
Who may be able to join
- Signing the Informed Voluntary Consent Form
- Being in the age range of 18-25
Who cannot join
- having a sleep disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Sleep Quality and Cognition in Young Adults
Sleep quality is impaired in young adults due to current conditions. Recent studies emphasize that this situation may also affect the cognitive status of individuals. The aim of this study was to investigate the relationship between sleep quality and cognitive status in young adults. A total of 122 young adults (61 female, 61 male) aged between 18 to 25 and studied at Istanbul Medipol University, Faculty of Health Sciences, were included in the study. Individuals were evaluated with "Pittsburgh Sleep Quality Index (PSQI)" for sleep quality; with "Montreal Cognitive Status Scale (MoCA)" for cognitive status, with "STROOP Test" for selective attention; with "Verbal Fluency Test" for sustained attention; with "WMS-R digit Span Test" for auditory attention
- Conditions
- Healthy Adults
- Being tested
- Cognitive Assessment (not diagnostic)
- Keywords
- Sleep Quality, Cognitive Status, healthy adult
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Assessment (not diagnostic)Other
Sleep quality and cognition will be assessed in young adults
| Study group | Role | What they receive |
|---|---|---|
| Study Group | A group of young adults aged between 18 to 25 Receives: Other: Cognitive Assessment (not diagnostic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index evaluates sleep quality and impairment in the last one month. 19 of the 24 PSQIquestions included were self-report questions. The scale has 18 questions and 7 components: Subjective Sleep Quality "," Sleep Latency "," Sleep Duration ", "Sleep Efficiency", "Sleep Disturbance", "Sleep Medication" and Daytime Dysfunction". The total score ranges from 0-21. A total score greater than 5 indicates poor sleep quality.
Measured: 8 March - 26 April 2019
Montreal Cognitive Assessment Test
Montreal Cognitive Assessment Test (MoCA) examines cognitive abilities such as visual / executive function, naming, episodic memory, attention, language, abstract thinking, and orientation. The original cut-off score of the MoCA test is 26. The cut-off score of 21 was adopted in Turkey. MoCA takes about 10 minutes to apply, but shortened versions have been created to shorten the administration time
Measured: 8 March - 26 April 2019
Secondary outcomes (3)
STROOP Test
The Stroop Test reflects selective attention, reading and color rendering processes. It is a critical experimental task, often used in the study of automatic and parallel processing models with the speed of information processing. Because of these features, the test is used not only in the evaluation of the cognitive processes of healthy individuals, but also in the evaluation of many psychiatric and neurological disorders
Measured: 8 March - 26 April 2019
Verbal Fluency Test
Verbal Fluency Test evaluates the tasks performed with frontal and temporal lobe activation. The purpose of this test is to evaluate the mental recall of words starting with the given letter or in the desired category within the prescribed time.
Measured: 8 March - 26 April 2019
WMS-R digit Span Test
Digit Span Test is the eighth subtest in the Wechsler Memory Scale Developed Form, and evaluates the simple and complex attention of individuals. This sub-test consists of two sub-sections, and a series of increasingly long numbers are read to the person. Both subtests are related to auditory attention and short-term memory. Two separate trials are made for each length sequence.
Measured: 8 March - 26 April 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start8 Mar 2019
- Primary completion26 Apr 2019
- Study completion21 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mbudak, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845464
- Sponsor's protocol ID
- SleepCog2021
- Status last verified
- Apr 2021
- First submitted
- 10 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Sleep Quality and Cognition in Young Adults
- ClinicalTrials.gov ID
- NCT04845464
- Acronym / sponsor ID
- SleepCog2021
- Conditions
- Healthy Adults
- Keywords
- Sleep Quality, Cognitive Status, healthy adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 15 Apr 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.
Sleep quality is impaired in young adults due to current conditions. Recent studies emphasize that this situation may also affect the cognitive status of individuals. The aim of this study was to investigate the relationship between sleep quality and cognitive status in young adults. A total of 122 young adults (61 female, 61 male) aged between 18 to 25 and studied at Istanbul Medipol University, Faculty of Health Sciences, were included in the study. Individuals were evaluated with "Pittsburgh Sleep Quality Index (PSQI)" for sleep quality; with "Montreal Cognitive Status Scale (MoCA)" for cognitive status, with "STROOP Test" for selective attention; with "Verbal Fluency Test" for sustained attention; with "WMS-R digit Span Test" for auditory attention
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Cognitive Assessment (not diagnostic)A group of young adults aged between 18 to 25 |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults aged between 18 to 25
Key inclusion criteria (2 listed)
- Signing the Informed Voluntary Consent Form
- Being in the age range of 18-25
Key exclusion criteria (1 listed)
- having a sleep disorder
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 |
|---|---|---|
| Cognitive Assessment (not diagnostic)Sleep quality and cognition will be assessed in young adults | Other | Study Group |
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: 8 March - 26 April 2019
Pittsburgh Sleep Quality Index evaluates sleep quality and impairment in the last one month. 19 of the 24 PSQIquestions included were self-report questions. The scale has 18 questions and 7 components: Subjective Sleep Quality "," Sleep Latency "," Sleep Duration ", "Sleep Efficiency", "Sleep Disturbance", "Sleep Medication" and Daytime Dysfunction". The total score ranges from 0-21. A total score greater than 5 indicates poor sleep quality.
Montreal Cognitive Assessment Test
Time frame: 8 March - 26 April 2019
Montreal Cognitive Assessment Test (MoCA) examines cognitive abilities such as visual / executive function, naming, episodic memory, attention, language, abstract thinking, and orientation. The original cut-off score of the MoCA test is 26. The cut-off score of 21 was adopted in Turkey. MoCA takes about 10 minutes to apply, but shortened versions have been created to shorten the administration time
3 secondary outcomes
STROOP Test
Time frame: 8 March - 26 April 2019
Verbal Fluency Test
Time frame: 8 March - 26 April 2019
WMS-R digit Span Test
Time frame: 8 March - 26 April 2019
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 19 Apr 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 Healthy Adults, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 19 Apr 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 Turkey (Türkiye). 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?
Pittsburgh Sleep Quality Index (time frame: 8 March - 26 April 2019). The study lists 2 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 19 Apr 2021.