Validation of a low cost manometer to evaluate upper airway oropharyngeal muscle strength

Validation of the OMES questionnaire compared to objective measurement of oropharyngeal muscle tone using the IOPI manometer, Sandway manometer, and digital spoon

Registry ID
ISRCTN49446863
Source registry
ISRCTN
Status
No longer recruiting
Study type
OBSERVATIONAL
Sponsor
Hospital Quirosalud Marbella
Enrollment
60
Start date
2025-05-05
Completion date
2026-08-01
Last update
2026-08-17

Conditions

Summary

Obstructive sleep apnea

Detailed description

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, participants complete the OMES questionnaire and undergo muscle tone assessments using the IOPI® manometer, Sandway® manometer, and a digital spoon. All tests are performed by a trained speech therapist and recorded for later blinded assessment. The total duration of observation is approximately 1 hour. There is no longitudinal follow-up; data collection is completed in a single session.

Interventions

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 < 7 points Previous inclusion criteria: Cases: 1. Age between 18 and 75 years 2. Diagnosis of moderate to severe OSAHS (AHI >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

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)

Locations

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