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

NCT07181642 | Completed

• 1 other identifier: DB-SB-RCT-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Bruxism; Bruxism, Sleep-Related

Outcome Measures

Primary Outcomes (1)

• Sleep Bruxism Frequency

  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

Study Arms (2)

Experimental Group - Diaphragmatic Breathing

EXPERIMENTAL

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

Behavioral: Diaphragmatic Breathing Program

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Diaphragmatic Breathing Program BEHAVIORAL

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

Also known as: Deep Breathing Exercises

Experimental Group - Diaphragmatic Breathing

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

Also known as: placebo

Placebo Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Clinically diagnosed sleep bruxism
• Provision of consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Hospital Habib Bougatfa Bizerte

Bizerte, 7000, Tunisia

Location

MeSH Terms

Conditions

Bruxism; Sleep Bruxism

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant, Removable Partial Dentures

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: September 15, 2025
• Primary Completion: October 30, 2025
• Study Completion: November 14, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

TU (1)