Diaphragmatic Breathing for Sleep Bruxism in Adults: A Randomized Controlled Trial (DB4SB)

November 14, 2025 updated by: Chtioui Hajer, University of Monastir

Efficacy of a Diaphragmatic Breathing Program in Adults With Sleep Bruxism: A Randomized Controlled Trial

The goal of this clinical trial is to learn if a diaphragmatic breathing program can reduce sleep bruxism in adults. The main questions it aims to answer are:

Can diaphragmatic breathing lower the frequency of teeth grinding during sleep?

Can it reduce jaw discomfort and improve sleep quality?

Participants will:

Attend sessions to learn diaphragmatic breathing exercises

Practice these exercises daily at home for 4 weeks

Complete questionnaires and clinical assessments before and after the program

Participation is safe, with minimal risks, such as mild fatigue during exercises. The study will help determine if diaphragmatic breathing is an effective way to manage sleep bruxism

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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

  • Tunisia
      • Bizerte, Tunisia, 7000
        • Hospital Habib Bougatfa Bizerte

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:

  • Clinically diagnosed sleep bruxism
  • Provision of consent

Exclusion Criteria:

  • • Current use of medications affecting sleep or neuromuscular function

    • History of severe neurological or psychiatric disorders
    • Ongoing use of a dental reconditioning splint or occlusal device
    • Inability to informed consent

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group - Diaphragmatic Breathing
Participants will learn and practice diaphragmatic breathing exercises daily for 4 weeks.
Behavioral: Diaphragmatic Breathing Program
Participants will learn diaphragmatic breathing exercises and practice them daily for 4 weeks before bedtime.
Other Names:
  • Deep Breathing Exercises
Placebo Comparator: Placebo Group
Participants will listen to neutral music of the same duration before sleep. This activity does not include any therapeutic breathing exercises and is intended as a control.
Behavioral: Neutral Music Listening
Participants will listen to neutral music of the same duration before sleep. This activity does not include any therapeutic breathing exercises and is intended as a control
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Bruxism Frequency
Time Frame: 4 weeks
The frequency of sleep bruxism episodes will be assessed using the standardized STAB questionnaire and patient self-reports. Measurements will be taken at baseline (before starting the intervention) and at the end of the 4-week program to determine any change in bruxism frequency.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Monastir

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)

September 15, 2025

Primary Completion (Actual)

October 30, 2025

Study Completion (Actual)

November 14, 2025

Study Registration Dates

First Submitted

September 11, 2025

First Submitted That Met QC Criteria

September 11, 2025

First Posted (Estimated)

September 18, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DB-SB-RCT-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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