Effects of respiratory muscle training on tongue muscle function in healthy subjects, randomized controlled trial.
Zusammenfassung der Studie
In the presence of obstructive sleep apnea syndrome (OSAS), the standard treatment consists of a device. During sleep, it is possible to develop obstructive sleep apnea syndrome (OSAS). This is the result of the closure of the upper airways (muscles that are between the mouth and the trachea). Recent studies have shown that respiratory muscle training leads to improved tone of these muscles and limits this closure of the upper airways. To propose other therapeutic options to patients with OSAS, we would like to test different training modalities in healthy subjects in order to later direct patients to the most effective modality. In this study, we examine the effect of respiratory muscle training on the strength and endurance of the tongue muscles.
(BASEC)
Untersuchte Intervention
In our study, participants are randomly assigned to four groups, a method called randomization, to obtain reliable results: • IMT Group: Follows an inspiratory muscle exercise program for 8 weeks, with 2 sessions per day, 5 days a week. • EMT Group: Follows an expiratory muscle program for 8 weeks, with 2 sessions per day, 5 days a week. • THOLD Group: Follows an expiratory muscle program with minimal resistance for 8 weeks, with 1 session per day, 5 days a week. • CTRL Group (Control): Does not follow any training for 8 weeks. These tests will allow us to see which type of training is the most effective.
(BASEC)
Untersuchte Krankheit(en)
Healthy subjects with a view to applying it to patients diagnosed with obstructive sleep apnea syndrome
(BASEC)
-Healthy adults aged 18 to 65 years from the day of the test (BASEC)
Ausschlusskriterien
-Body mass index (BMI ≤ 18 and ≥ 30 kg/m²) (BASEC)
Studienstandort
Lausanne
(BASEC)
Sponsor
Sponsor Haute Ecole de Santé Vaud Sponsor étranger Université Catholique de Louvain
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Olivier Contal
+41 21 316 81 22
olivier.contal@clutterhesav.chHaute Ecole de Santé Vaud (Lausanne)
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Waadt
(BASEC)
Datum der Bewilligung durch die Ethikkommission
11.03.2025
(BASEC)
ICTRP Studien-ID
NCT06627283 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Effects of Respiratory Muscle Training on Tongue Muscle Function (BASEC)
Wissenschaftlicher Titel
Effects of Respiratory Muscle Training on Tongue Muscle Function in Healthy Subjects, a Randomized Controlled Trial. (ICTRP)
Öffentlicher Titel
Effects of Respiratory Muscle Training on Tongue Muscle Function (ICTRP)
Untersuchte Krankheit(en)
Healthy (ICTRP)
Untersuchte Intervention
Device: IMT;Device: EMT;Device: Sham (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Gender: All
Maximum age: 65 Years
Minimum age: 18 Years
Inclusion Criteria:
Community ambulant adults between 18 to 65 years old as of testing day; able to
understand French or Dutch (depending on the study's site of inclusion); BMI = 18 and =
30 kg/m?.
Exclusion Criteria:
Any diagnosed neuromuscular or cardiorespiratory disease; diagnosed psychiatric or
psychological disorders which could affect adherence to or comprehension of instructions;
diagnosed eating disorders; previous or ongoing head and neck cancer; diagnosed OSA;
presenting a high-risk of sleep-disordered breathing indicated by a NoSAS score of 8 or
higher 32 or a STOP-Bang score of 3 or higher 33,34; resting heart rate (HR) > 100
beats per minute (bpm) or < 50 bpm; resting systolic blood pressure (SBP) > 140 or
< 90 mmHg, diastolic blood pressure (DBP) > 90 or < 50 mmHg; oxygen saturation
(SpO2) < 94% at rest on room air. Individuals with abnormal lung function, i.e.,
forced expiratory volume in 1 second (FEV1) = 80%, forced vital capacity (FVC) = 80%, and
FEV1/FVC = 70%, will also be excluded. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Tongue elevation strength (ICTRP)
Tongue protrustion strength;Tongue elevation endurance;Tongue protrusion endurance;Maximal inspiratory pressure;Maximal expiratory pressure;Snoring intensity;Tongue base thickness;Total sagittal thickness;Lateral pharyngeal wall thickness;Snoring duration (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
William Poncin, william.poncin@uclouvain.be, +3227642316 (ICTRP)
Sekundäre IDs
RMT-TONGUE (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06627283 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar