Completed

NCT Number: NCT07181642

Diaphragmatic Breathing for Sleep Bruxism in Adults: 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

Completed

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Key information

Conditions

Bruxism Behavior Bruxism, Sleep-Related Habits Mental Disorders Nervous System Diseases Parasomnias Sleep Bruxism Sleep Wake Disorders Stomatognathic Diseases Tooth Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Habib Bougatfa Bizerte

Bizerte, 7000, Tunisia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diaphragmatic Breathing Program

Behavioral

Participants will learn diaphragmatic breathing exercises and practice them daily for 4 weeks before bedtime.

Other names: Deep Breathing Exercises

Neutral Music Listening

Behavioral

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

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

Acronym: DB4SB

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Sep 18, 2025
Registry last updated: Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed