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

University of Monastir

Status: Not yet enrolling

Conditions: Bruxism; Bruxism, Sleep-Related

Treatments: Behavioral: Neutral Music Listening; Behavioral: Diaphragmatic Breathing Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07181642

DB-SB-RCT-2025

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Experimental Group - Diaphragmatic Breathing

Experimental group

Description:

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

Treatment:

Behavioral: Diaphragmatic Breathing Program

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Neutral Music Listening