Effects of respiratory muscle training on tongue muscle function in healthy subjects, randomized controlled trial.
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
-Body mass index (BMI ≤ 18 and ≥ 30 kg/m²) (BASEC)
Luogo dello studio
Losanna
(BASEC)
Sponsor
Sponsor Haute Ecole de Santé Vaud Sponsor étranger Université Catholique de Louvain
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Olivier Contal
+41 21 316 81 22
olivier.contal@clutterhesav.chHaute Ecole de Santé Vaud (Lausanne)
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Vaud
(BASEC)
Data di approvazione del comitato etico
11.03.2025
(BASEC)
ID di studio ICTRP
NCT06627283 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Effects of Respiratory Muscle Training on Tongue Muscle Function (BASEC)
Titolo accademico
Effects of Respiratory Muscle Training on Tongue Muscle Function in Healthy Subjects, a Randomized Controlled Trial. (ICTRP)
Titolo pubblico
Effects of Respiratory Muscle Training on Tongue Muscle Function (ICTRP)
Malattie studiate
Healthy (ICTRP)
Intervento studiato
Device: IMT;Device: EMT;Device: Sham (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
William Poncin, william.poncin@uclouvain.be, +3227642316 (ICTRP)
ID secondari
RMT-TONGUE (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06627283 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile