Evaluation of muscle activity patterns in patients with severe obstructive sleep apnea

Validation of Orofacial Myofunctional Evaluation Protocol with Scores (OMES) with objective measurement of oropharyngeal muscle tone using Iowa Oral Performance Instrument (IOPI) and tongue digital spoon in severe obstructive sleep apnea hypopnea syndrome (OSAHS)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN12596010

Enrollment

Registered

2021-03-24

Start date

2021-04-07

Completion date

Unknown

Last updated

2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep apnoea, severe obstructive sleep apnea-hypopnea syndrome Nervous System Diseases Sleep apnoea

Interventions

A myofunctional evaluation of the patient diagnosed with OSAHS will be conducted in the same week as the polysomnography is performed. During this evaluation, patients are blindly examined by a speech

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 29/03/2021: Cases: 1. Ages between 18 and 75 years 2. Diagnosis of moderate to severe OSAHS (AHI>30) without having had previous experience of said condition and not undergoing treatment due to different circumstances 3. Not having undergone any previous treatment for OSAHS 4. Signed informed consent (IC) form Controls: 1. Adequate sleep hygiene 2. No complaints of snoring 3. No complaints of daytime sleepiness 4. Epworth Scale 15) without having had previous experience of said condition and not undergoing treatment due to different circumstances 3. Not having undergone any previous treatment for OSAHS 4. Signed informed consent (IC) form Controls: 1. Adequate sleep hygiene 2. No complaints of snoring 3. No complaints of daytime sleepiness 4. Epworth Scale <7 points

Exclusion criteria

Exclusion criteria: 1. Cognitive or neurological deficit 2. Inability to answer questionnaires 3. Severe alcoholism 4. Presence of craniofacial malformations 5. Active neoplastic disease 6. History of prior orofacial muscle rehabilitation therapy and any prior apnoea treatment which may modify the study results (surgery, MAD, CPAP)

Design outcomes

Primary

Measure	Time frame
Function of the stomatognathic musculature of patients measured a single time point using: 1. The OMES protocol (visual inspection) 2. The digital spoon to measure tongue pressure 3. The IOPI (Iowa Oral Performance Instrument) to measure tongue strength and resistance with the genioglossus and buccinator muscle tone	—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026