NCT05829525

Brief Summary

This study aims to evaluate the relationship among sleep duration, heart rate, number of steps, and sleep quality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 8, 2025

Status Verified

September 1, 2023

Enrollment Period

1.5 years

First QC Date

March 12, 2023

Last Update Submit

April 7, 2025

Conditions

Keywords

Step countPhysical activityHeart rateSleep qualitySleep duration

Outcome Measures

Primary Outcomes (5)

  • 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".

    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.

    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.

    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.

    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.

    1 day

Study Arms (1)

Healthy young adults group

OTHER

Face-to-face assessment study

Other: Evaluation of sleep quality, sleep duration, heart rate and step count

Interventions

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

Healthy young adults group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • With any neurological, psychiatric or cognitive impairment,
  • Who cannot speak, read or write Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, Merkez, 60250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivitySleep Initiation and Maintenance Disorders

Interventions

Sleep DurationHeart Rate

Condition Hierarchy (Ancestors)

BehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

SleepNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaVital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 12, 2023

First Posted

April 25, 2023

Study Start

January 1, 2023

Primary Completion

July 1, 2024

Study Completion

December 31, 2024

Last Updated

April 8, 2025

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations