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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Healthy young adults group
Face-to-face assessment study
Other: Evaluation of sleep quality, sleep duration, heart rate and step count
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tokat Gaziosmanpasa University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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