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

NCT07181642 — Not applicable, Completed, 100 participants, University of Monastir

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

Registry	NCT07181642, acronym DB4SB
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	100 (Actual)
Sponsor	University of Monastir (Other)
Conditions	Bruxism, Bruxism, Sleep-Related
Interventions	Diaphragmatic Breathing Program, Neutral Music Listening (Behavioral)
Dates	start 2025-09-15, primary completion 2025-10-30, completion 2025-11-14, first posted 2025-09-18, last updated 2025-11-19
Locations	1 site in Tunisia

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Experimental Group - Diaphragmatic Breathing	Experimental	Behavioral: Diaphragmatic Breathing Program	Participants will learn and practice diaphragmatic breathing exercises daily for 4 weeks.
Placebo Group	Placebo comparator	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.

Diaphragmatic Breathing Program (Behavioral), also known as Deep Breathing Exercises: Participants will learn diaphragmatic breathing exercises and practice them daily for 4 weeks before bedtime.
Neutral Music Listening (Behavioral), also known as placebo: 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

+Outcome measures

Primary outcomes

Sleep Bruxism Frequency [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.

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Hospital Habib Bougatfa Bizerte	Bizerte	Tunisia