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Measuring muscle function in patients with obstructive sleep apnea

Myofunctional evaluation as a part of the diagnosis of obstructive sleep apnea

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN58267316
Enrollment
90
Registered
2024-11-14
Start date
2023-11-05
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Obstructive sleep apnea (OSA) Nervous System Diseases

Interventions

ENT office exam, polysomnography and myofunctional evaluation including breathing type, lip sealing, lingual frenulum and evaluation of muscle strength of the lingual and oral muscles with the IOPI.

Sponsors

Hospital Universitario de Fuenlabrada
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients scheduled for septoplasty evaluated to screen for OSA at the Otorhinolaryngology Department

Exclusion criteria

Exclusion criteria: 1. Systemic disease with a known inflammatory state 2. Presence of a muscle rehabilitation treatment 3. Previous nasal surgery 4. Previous OSA treatment (CPAP, surgery, or mandibular advancement device)

Design outcomes

Primary

MeasureTime frame
Polysomnography assessed with the Apnea-Hypopnea Index (AHI), with mild OSA defined as >5 events/h of sleep, moderate OSA as 15–29.9 events/h of sleep, and severe OSA as =30 events/h of sleep at one timepoint

Secondary

MeasureTime frame
The following secondary outcome measures are assessed at one timepoint: 1. Anatomical findings in the upper airway from the nasal valve area to the larynx: 1.1. Friedman tonsil grading, scaled from 1 to 5 1.2. Height of the hard palate, measured in centimeters 1.3. Friedman tongue position (FTP), scaled from 1 to 5 1.4. Mallampati scales, scaled from 1 to 5 1.5. Basilingual hypertrophy assessed with lingual tonsil hypertrophy (LTH) Friedman classification, scaled from 1 to 5 1.6. Awake dynamic exam with Müller maneuver, considered collapsed or not 2. Myofunctional exam: 2.1. Breathing (nasal or oral) 2.2. Lingual sealing (opened or closed) 2.3. Lingual frenulum assessed using the Marchesani protocol (present or not) 2.4. Muscle strength evaluated with the Iowa Oral Performance Instrument (IOPI) in KiloPascals at buccinator and tongue propulsion

Countries

Spain

Contacts

Public ContactGuillermo Plaza
guillermo.plaza@salud.madrid.org+34 (0)679472218

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026