NCT05762913

Brief Summary

Even in healthy individuals, there may be tensions in the diaphragm muscle due to factors such as wrong posture, wrong breathing pattern, sedentary lifestyle, and it cannot fully fulfill its function. As a result of this tension in the diaphragm muscle, the breathing pattern deteriorates and sleep quality decreases. The aim of this study is to examine the effect of diaphragm release technique on sleep duration and sleep quality in healthy individuals. In this study, sleep quality of individuals will be evaluated with Pittsburgh Sleep Quality Index (PUKI), sleep duration, heart rate and step count with Fitbit® Inspire 2. 32 individuals living in Tokat will be included in the study. After obtaining the sociodemographic information of the individuals, the average of sleep duration, heart rate and step counts will be recorded for 3 days with the Fitbit® Inspire 2 wearable technology to be provided within the scope of the project. Sleep quality will be recorded with PUKI. The diaphragm release technique will be applied in 3 sessions, with 2 days of rest in between. After the applications are finished, sleep time, heart rate and step counts will be recorded for 3 days with Fitbit® Inspire 2 wearable technology.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 19, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

11 months

First QC Date

February 19, 2023

Last Update Submit

September 11, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Pittsburgh Sleep Quality Index

    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 sub-dimensions 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"

    Baseline

  • Pittsburgh Sleep Quality Index

    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 sub-dimensions 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"

    3rd day

  • Sleep Time

    Measurements will be made with the Fitbit® Inspire 2 device

    3rd day

  • Heart Rate

    Measurements will be made with the Fitbit® Inspire 2 device

    3rd day

  • Step Count

    Measurements will be made with the Fitbit® Inspire 2 device

    3rd day

Study Arms (1)

Diaphragm release

EXPERIMENTAL

The therapist passes his fingers under the costal arch, during inspiration the therapist accompanies the movement of the ribs, while during expiration he takes his fingers deeper, increasing his pressure. The therapist progresses progressively deeper into the costal arch with each breath. The maneuver will be performed in two sets of 10 deep breaths. The diaphragm release technique will be applied in 3 sessions, with 2 days of rest in between.

Other: Manual Diaphragm Release Technique

Interventions

The therapist passes his fingers under the costal arch, during inspiration the therapist accompanies the movement of the ribs, while during expiration he takes his fingers deeper, increasing his pressure. The therapist progresses progressively deeper into the costal arch with each breath. The maneuver will be performed in two sets of 10 deep breaths. The diaphragm release technique will be applied in 3 sessions, with 2 days of rest in between.

Diaphragm release

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals between the ages of 18-65 who do not have any chronic disease or any past or present psychological disorder will be included.

You may not qualify if:

  • Individuals with any neurological, psychiatric or cognitive impairment will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences, Tokat Gaziosmanpaşa University

Tokat Province, 60250, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Erol E, Kurtbogan M. The effects of diaphragm release on sleep quality: a pilot feasibility study. BMC Pulm Med. 2025 Oct 15;25(1):471. doi: 10.1186/s12890-025-03968-4.

Central Study Contacts

Erkan Erol

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 19, 2023

First Posted

March 10, 2023

Study Start

March 30, 2023

Primary Completion

March 1, 2024

Study Completion

June 1, 2024

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations