Healthy Young AdultNCT05829525
Relationship Between Sleep Quality, Sleep Duration, Heart Rate, and Step Number
A study testing Evaluation of sleep quality, sleep duration, heart rate and step count in people with Healthy Young Adult, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the relationship among sleep duration, heart rate, number of steps, and sleep quality. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adult
- What is being tested?
- Evaluation of sleep quality, sleep duration, heart rate and step count
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Interventional
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-30,
- Without any chronic disease,
- No past or present mental illness,
- Can speak, read, and write Turkish and
- Who volunteered to participate in the study
Who cannot join
- With any neurological, psychiatric or cognitive impairment,
- Who cannot speak, read or write Turkish
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Tokat Province, Merkez, 60250
About this study
Official title: Relationship Between Sleep Quality, Sleep Duration, Heart Rate, and Step Number in Young Adults
This study aims to evaluate the relationship among sleep duration, heart rate, number of steps, and sleep quality.
Read the detailed description
There are studies examining the relationship between sleep quality and physical activity in young adults. In these studies, weakly significant relationships were recorded between sleep quality and physical activity level. However, in these studies, the level of physical activity was evaluated with the International Physical Activity Questionnaire and the questionnaire was filled in within the framework of certain activities. In this study, physical activity will be evaluated with the number of steps taken per day. In addition, there is no study examining the relationship between sleep quality, sleep duration, and heart rate in young adults. With the current study, parameters that will affect physical activity such as sleep duration, heart rate, and the number of steps will be evaluated and their relationship with sleep quality will be determined. Sleep quality will be assessed by the Pittsburgh Sleep Quality Index, sleep duration, heart rate, and step count will be assessed by the Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA), and quality of life will be assessed by the Nottingham Health Profile. The results will be analyzed using the SPSS version 22.0 computer package program.
- Conditions
- Healthy Young Adult
- Being tested
- Evaluation of sleep quality, sleep duration, heart rate and step count
- Keywords
- Step count, Physical activity, Heart rate, Sleep quality, Sleep duration
- Medical subject headings
- Motor Activity, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of sleep quality, sleep duration, heart rate and step countOther
Evaluation of sleep quality with the Pittsburgh Sleep Quality Index Evaluation of sleep duration, heart rate, and step count with the Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA) Evaluation of quality of life with the Nottingham Health Profile
| Study group | Role | What they receive |
|---|---|---|
| Healthy young adults group | Other | Face-to-face assessment study Receives: Other: Evaluation of sleep quality, sleep duration, heart rate and step count |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality. PSQI is a scale that provides information on sleep quality and the type and severity of sleep disturbance in the past week. Turkish validity and reliability were established. In the scale consisting of 24 questions in total, 19 questions are answered by the person, while the other 5 questions are filled by the person's bedmate. 7 sub-dimensions (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, daytime dysfunction) are evaluated with 19 questions answered by the individual. Each item in the scale scores between 0 (no distress)-3 (severe distress). The sum of the scores of the seven subdimensions gives the total PSQI score (between 0-21). Those with a total score of 5≥ "good sleep", and those with a score of 5< are considered "poor sleep quality".
Measured: 1 day
Sleep duration
Sleep time will be evaluated with the Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA). Individuals will wear a Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA) on one wrist. During a day, individuals' sleep duration will be recorded. They will be asked to continue with their normal routines, in abnormal cases the measurement will be repeated. Data will be transferred via Bluetooth to smartphones or tablets accessible via the Fitbit App. Individuals' privacy will be protected by downloading the Fitbit app only to the principal investigator's device and creating separate accounts, one for each Fitbit device, without providing personal information.
Measured: Single assessment for 1 day
Nottingham Health Profile
The Nottingham Health Profile (NHP) will be used to assess quality of life. The NHP is a general quality of life questionnaire that measures the perceived health problems and the extent to which these problems affect normal daily activities. The questionnaire consists of 38 items. Questions are answered as 'yes' or 'no'. The questionnaire assesses six parameters related to health status. These parameters are; pain (8 items), physical activity (8 items), energy (3 items), sleep (5 items), social isolation (5 items), emotional reactions (9 items). Each subparameter is scored between 0-100. 0 indicates best health, 100 indicates worst health. The total NHP score is derived from the sum of the subscores.
Measured: 1 day
Heart rate
Heart rate count will be evaluated with the Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA). Individuals will wear a Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA) on one wrist. During a day, individuals' heart rate will be recorded. They will be asked to continue with their normal routines, in abnormal cases the measurement will be repeated. Data will be transferred via Bluetooth to smartphones or tablets accessible via the Fitbit App. Individuals' privacy will be protected by downloading the Fitbit app only to the principal investigator's device and creating separate accounts, one for each Fitbit device, without providing personal information.
Measured: 1 day
Step count
Step count will be evaluated with the Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA). Individuals will wear a Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA) on one wrist. During a day, individuals' step count will be recorded. They will be asked to continue with their normal routines, in abnormal cases the measurement will be repeated. Data will be transferred via Bluetooth to smartphones or tablets accessible via the Fitbit App. Individuals' privacy will be protected by downloading the Fitbit app only to the principal investigator's device and creating separate accounts, one for each Fitbit device, without providing personal information.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Jan 2023
- Primary completion1 Jul 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Young AdultStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime Arikan, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829525
- Sponsor's protocol ID
- 83116987-614
- Status last verified
- Sep 2023
- First submitted
- 12 Mar 2023
- Last updated
- 8 Apr 2025
- 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 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Sleep Quality, Sleep Duration, Heart Rate, and Step Number in Young Adults
- ClinicalTrials.gov ID
- NCT05829525
- Acronym / sponsor ID
- 83116987-614
- Conditions
- Healthy Young Adult
- Keywords
- Step count, Physical activity, Heart rate, Sleep quality, Sleep duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 Apr 2023 (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.
This study aims to evaluate the relationship among sleep duration, heart rate, number of steps, and sleep quality.
Detailed description
There are studies examining the relationship between sleep quality and physical activity in young adults. In these studies, weakly significant relationships were recorded between sleep quality and physical activity level. However, in these studies, the level of physical activity was evaluated with the International Physical Activity Questionnaire and the questionnaire was filled in within the framework of certain activities. In this study, physical activity will be evaluated with the number of steps taken per day. In addition, there is no study examining the relationship between sleep quality, sleep duration, and heart rate in young adults. With the current study, parameters that will affect physical activity such as sleep duration, heart rate, and the number of steps will be evaluated and their relationship with sleep quality will be determined. Sleep quality will be assessed by the Pittsburgh Sleep Quality Index, sleep duration, heart rate, and step count will be assessed by the Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA), and quality of life will be assessed by the Nottingham Health Profile. The results will be analyzed using the SPSS version 22.0 computer package program.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy young adults group | Other | Other: Evaluation of sleep quality, sleep duration, heart rate and step countFace-to-face assessment study |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between the ages of 18-30,
- Without any chronic disease,
- No past or present mental illness,
- Can speak, read, and write Turkish and
- Who volunteered to participate in the study
Key exclusion criteria (2 listed)
- With any neurological, psychiatric or cognitive impairment,
- Who cannot speak, read or write Turkish
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 |
|---|---|---|
| Evaluation of sleep quality, sleep duration, heart rate and step countEvaluation of sleep quality with the Pittsburgh Sleep Quality Index Evaluation of sleep duration, heart rate, and step count with the Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA) Evaluation of quality of life with the Nottingham Health Profile | Other | Healthy young adults group |
Primary outcome
Sleep quality
Time frame: 1 day
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality. PSQI is a scale that provides information on sleep quality and the type and severity of sleep disturbance in the past week. Turkish validity and reliability were established. In the scale consisting of 24 questions in total, 19 questions are answered by the person, while the other 5 questions are filled by the person's bedmate. 7 sub-dimensions (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, daytime dysfunction) are evaluated with 19 questions answered by the individual. Each item in the scale scores between 0 (no distress)-3 (severe distress). The sum of the scores of the seven subdimensions gives the total PSQI score (between 0-21). Those with a total score of 5≥ "good sleep", and those with a score of 5< are considered "poor sleep quality".
Sleep duration
Time frame: Single assessment for 1 day
Sleep time will be evaluated with the Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA). Individuals will wear a Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA) on one wrist. During a day, individuals' sleep duration will be recorded. They will be asked to continue with their normal routines, in abnormal cases the measurement will be repeated. Data will be transferred via Bluetooth to smartphones or tablets accessible via the Fitbit App. Individuals' privacy will be protected by downloading the Fitbit app only to the principal investigator's device and creating separate accounts, one for each Fitbit device, without providing personal information.
Nottingham Health Profile
Time frame: 1 day
The Nottingham Health Profile (NHP) will be used to assess quality of life. The NHP is a general quality of life questionnaire that measures the perceived health problems and the extent to which these problems affect normal daily activities. The questionnaire consists of 38 items. Questions are answered as 'yes' or 'no'. The questionnaire assesses six parameters related to health status. These parameters are; pain (8 items), physical activity (8 items), energy (3 items), sleep (5 items), social isolation (5 items), emotional reactions (9 items). Each subparameter is scored between 0-100. 0 indicates best health, 100 indicates worst health. The total NHP score is derived from the sum of the subscores.
Heart rate
Time frame: 1 day
Heart rate count will be evaluated with the Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA). Individuals will wear a Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA) on one wrist. During a day, individuals' heart rate will be recorded. They will be asked to continue with their normal routines, in abnormal cases the measurement will be repeated. Data will be transferred via Bluetooth to smartphones or tablets accessible via the Fitbit App. Individuals' privacy will be protected by downloading the Fitbit app only to the principal investigator's device and creating separate accounts, one for each Fitbit device, without providing personal information.
Step count
Time frame: 1 day
Step count will be evaluated with the Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA). Individuals will wear a Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA) on one wrist. During a day, individuals' step count will be recorded. They will be asked to continue with their normal routines, in abnormal cases the measurement will be repeated. Data will be transferred via Bluetooth to smartphones or tablets accessible via the Fitbit App. Individuals' privacy will be protected by downloading the Fitbit app only to the principal investigator's device and creating separate accounts, one for each Fitbit device, without providing personal information.
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 8 Apr 2025.
- 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?
A study testing Evaluation of sleep quality, sleep duration, heart rate and step count in people with Healthy Young Adult, run by Tokat Gaziosmanpasa University 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 5 inclusion and 2 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 8 Apr 2025. 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?
Sleep quality (time frame: 1 day). The study lists 5 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 8 Apr 2025.