Obstructive sleep apnea Ear, Nose and Throat
Conditions
Interventions
Participants are enrolled after signing informed consent and screened to confirm eligibility (OSAHS diagnosis for cases
good sleep hygiene and absence of symptoms for controls). The study consists of a single evaluation visit taking place during the same week as the patient’s sleep study. During this visit, participant
data collection is completed in a single session.
Sponsors
Hospital Quirosalud Marbella
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 07/07/2026: Cases: 1. Age between 18 and 75 years 2. Diagnosis of severe obstructive sleep apnea (AHI >30 events/hour) with no previous treatment experience 3. No prior treatment for OSAHS 4. Signed informed consent (IC) Controls: 1. Adequate sleep hygiene 2. No complaints of snoring 3. No complaints of daytime sleepiness 4. Epworth Sleepiness Scale 15) with no previous treatment experience 3. No prior treatment for OSAHS 4. Signed informed consent (IC) Controls: 1. Adequate sleep hygiene 2. No complaints of snoring 3. No complaints of daytime sleepiness 4. Epworth Sleepiness Scale < 7 points
Exclusion criteria
Exclusion criteria: 1. Cognitive or neurological deficits 2. Inability to complete questionnaires 3. Severe alcoholism 4. Presence of craniofacial malformations 5. Active neoplastic disease 6. History of orofacial muscle rehabilitation or prior OSA treatment (surgery, MAD, CPAP)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Orofacial muscle function measured using the OMES questionnaire at baseline (single visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tongue and buccinator muscle strength measured using the IOPI® manometer at baseline (single visit). Measured in kilopascals (kps). 2. Tongue pressure measured using the Sandway® manometer at baseline (single visit). Measured in kilopascals (kps). 3. Tongue strength measured using a digital spoon at baseline (single visit). Measured in gr/cm². 4. Correlation between OMES score and values obtained by IOPI®, Sandway®, and digital spoon, analyzed at baseline (single visit) Added 07/07/2026: Exploratory outcomes: 1. Presence and classification of the Palatal-Tongue Clinical Sign (PTCS sign) assessed during standardized oral clinical examination at baseline and after 3 months 2. Maxillary intermolar distance (palatal width) measured in millimetres using a digital caliper (vernier caliper) during the baseline clinical assessment | — |
Countries
Spain
Contacts
Public ContactCarlos O'Connor-Reina
Outcome results
None listed