- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05829525
Relationship Between Sleep Quality, Sleep Duration, Heart Rate, and Step Number
April 7, 2025 updated by: Halime ARIKAN, Tokat Gaziosmanpasa University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
116
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Merkez
-
Tokat, Merkez, Turkey, 60250
- Tokat Gaziosmanpasa University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- With any neurological, psychiatric or cognitive impairment,
- Who cannot speak, read or write Turkish
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Healthy young adults group
Face-to-face assessment study
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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".
|
1 day
|
|
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.
|
Single assessment for 1 day
|
|
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.
|
1 day
|
|
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.
|
1 day
|
|
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.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
July 1, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
March 12, 2023
First Submitted That Met QC Criteria
April 13, 2023
First Posted (Actual)
April 25, 2023
Study Record Updates
Last Update Posted (Actual)
April 8, 2025
Last Update Submitted That Met QC Criteria
April 7, 2025
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 83116987-614
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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