The Benefit of a Liraglutide-based Weight Management Alone or in Addition to Standard CPAP Therapy on Metabolic Function in Patients With Obstructive Sleep Apnoea (OSA) - an Explorative, Proof-of-concept Study

RS19-023

This is an explorative, proof-of-concept study exploring the potential therapeutic role of a Liraglutide-based weight loss regimen versus standard CPAP or the combination of both on metabolic parameters, blood pressure, endothelial function, coronary artery calcification, vascular inflammation and apnea/hypopnea index in non-diabetic patients with moderate to severe obstructive sleep apnea

2019-12-02

2021-12-31

2022-07-31

Completed

30

Inclusion Criteria: * Newly diagnosed moderate-severe OSA (by standard PSG) * Body mass index between 30 - 40 * Age 18 - 60 years * Able to provide written, informed consent Exclusion Criteria: * Pregnancy * Requirement for supplemental oxygen * Previous diagnosis of OSA or previous CPAP treatment * Diagnosis of Diabetes * Previous treatment with GLP-1 analogue * Previous surgical treatment for obesity * Active treatment for malignancy or severe psychiatric disorder * Acute coronary syndrome or stroke within 3 months prior to study * History of decompensated heart failure * Professional drivers or drivers with a history of road-traffic accident due to sleepiness * Severe excessive daytime sleepiness defined as Epworth sleepiness scale \>15

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

2023-12-18