Multi-level upper airway surgery in patients with moderate to severe obstructive sleep apnoea who have failed medical management.

Not Applicable

Completed

• Conditions: Obstructive sleep apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12614000338662
• Lead Sponsor: Prof. R. Doug McEvoy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Diagnosis of OSA (defined as Apnoea Hypopnoea Index, AHI, > 15 scored by AASM 2007 alternate criteria).
- At least mild daytime sleepiness defined as ESS (Epworth Sleepiness Scale) > 8. We used this cut point to target those with at least mild daytime sleepiness, but consider that the requirement for the ESS to be > 8 will not adversely affect recruitment.
- Failed CPAP treatment despite persistent, supervised attempts to implement CPAP, or been treated in a tertiary centre sleep lab or by an Australasian Sleep Association accredited sleep service and have not taken up CPAP when prescribed, and failed MAS therapy due to patient refusal, patient found to be unsuitable on dental grounds, patient intolerance, or were never offered MAS as a treatment option.
- CPAP treatment reduces AHI to below 15 events per hour of sleep (N/A for outright refusers of CPAP).
- Aged between 18 and 70 years.
- Body mass index (BMI) less than or equal to 38kg/m2. a)For patients with BMI 35-38: patient will be deemed appropriate provided they are of strong surgical/anatomical suitability, which consists of size 3-4 tonsil, with Friedman tongue 1-2, and dynamic assessment confirming predominant palatine tonsillar collapse

Exclusion Criteria

- Prior surgery on palate, tongue, mandible or maxilla. (Previous tonsillectomy is allowed.)
- Nasal obstruction uncontrolled by medication or surgery.
- Clinically significant retrognathia, confirmed by lateral skull x-ray (SNB angle < 72 degrees).
- Moderate to severe COPD (FEV/FVC ratio < 70% and FEV 1 <50%).
- Heart failure (New York Heart classes 2-4).
- Recent history (last 3 months) of a major cardiovascular event i.e. MI, unstable angina, CVA; or major disorder of the pulmonary, renal or nervous systems.
- Chronic narcotic use.
- Major depression i.e. hospitalisation for depression, suicide attempt or symptoms necessitating antidepressant drug dose escalation in the previous 3 months.
- Pregnant or breast feeding.
- Unacceptable anaesthetic or surgical risk (e.g. anticoagulant or antiplatelet medication which cannot be withdrawn).
- History of dysphagia or aspiration.
- Commercial driver.

Study & Design

• Study Type: Interventional
• Study Design: Not specified