Prevention of obstructive sleep apnea syndrome Nervous System Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Key inclusion criteria as of 13/07/2026: Inclusion criteria: (Cases) 1. Ages between 18 and 65 years. 2. Diagnosis of severe OSA (AHI >30 events/hour) with no previous experience of this disorder and untreated due to different circumstances. 3. Not to have used any previous treatment for severe OSA. 4. Signing of informed consent (IC). 5. Good permeability and nasal function. 6. Patients with pathological lingual frenulum diagnosed using Marchesani protocol and confirmed by a speech therapist. 7. Friedman 1 8. Palatine Tonsil Stage Friedman 1 Inclusion criteria: (Controls) 1. Ages between 18 and 65 years. 2. Diagnosis of severe OSA (AHI >30 events/hour) with no previous experience of this disorder and untreated due to different circumstances. 3. Not to have used any previous treatment for severe OSA. 4. Signing of informed consent (IC). 5. Good permeability and nasal function. 6. Patients with pathological lingual frenulum diagnosed using the Marchesani protocol and confirmed by a speech therapist. 7. To have refused frenuloplasty surgery. 8. Friedman 1 9. Palatine Tonsil Stage Friedman 1 Previous: Inclusion criteria: (Cases) 1. Ages between 18 and 65 years. 2. Diagnosis of moderate to severe OSA (AHI 15 to 30 in adults) with no previous experience of this disorder and untreated due to different circumstances. 3. Not to have used any previous treatment for severe OSA. 4. Signing of informed consent (IC). 5. Good permeability and nasal function. 6. Patients with pathological lingual frenulum diagnosed using the Marchesani protocol and confirmed by a speech therapist. 7. Friedman 1 8. Palatine Tonsil Stage Friedman 1 Inclusion criteria: (Controls) 1. Ages between 18 and 65 years. 2. Diagnosis of moderate to severe OSA (AHI 15- 30 in adults) with no previous experience of this disorder and untreated due to different circumstances. 3. Not to have used any previous treatment for severe OSA. 4. Signing of informed consent (IC). 5. Good permeability and nasal function. 6. Patients with pathological lingual frenulum diagnosed using the Marchesani protocol and confirmed by a speech therapist. 7. To have refused frenuloplasty surgery. 8. Friedman 1 9. Palatine Tonsil Stage Friedman 1
Exclusion criteria
Exclusion criteria: 1. Cognitive or neurological deficit 2. Inability to complete questionnaires 3. Severe alcoholism 4. BMI > 29 kg/m² 5. Active neoplastic disease 6. History of previous rehabilitative treatment of the orofacial musculature, as well as any previous apnoea treatment that may modify the results of the study (Surgery, MAD, CPAP) 7. Lack of smartphone access or inability to use one, or a home Internet network that prevents them from undergoing MT 8. Systemic diseases with muscle hypotonia 9. Pierre Robin Sequence or other severe craniofacial abnormalities 10. Problems with the temporomandibular joints that make it impossible to conduct MT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apnea hipoapnea index (AHI) (EVENTS/HOURS) preop and after 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. DISE findings with vote classification preop and after 3 months in both groups 2. Functional assessment preop and after 3 months in both groups 3. Epworth questionnaires preop and after 3 months in both groups 4. Oxygen desaturation index (ODI ) % preop and after 3 months in both groups 5. Iowa Oral Performance Instrument (IOPI) kilopascals preop and after 3 months in both groups 6. Vote classification preop and after 3 months in both groups Exploratory outcomes: 7. Palatal-Tongue Clinical Sign (PTCS sign), measured using standardized clinical examination at baseline (preoperative assessment), immediately after lingual frenuloplasty, and at 3 months following surgery 8. Palatal width, measured using the intermolar distance (mm) using a digital calliper at baseline (preoperative assessment) | — |
Countries
Spain