Effect of Liraglutide vs CPAP on Cardiometabolic Outcomes in Obstructive Sleep Apnea

St Vincent's University Hospital, Ireland

Status: Completed

Conditions: Sleep Apnea, Obstructive

Treatments: Device: Continuous positive airway pressure treatment; Combination Product: Liraglutide and CPAP; Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml

Study type: Interventional

Funder types: Other

Identifiers

NCT04186494

RS19-023

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 3 patient groups

Continuous positive airway pressure (CPAP)

Active Comparator group

Description:

Standard CPAP Therapy

Treatment:

Device: Continuous positive airway pressure treatment

Liraglutide-based weight loss regimen

Experimental group

Description:

Once daily s.c. injections of Liraglutide, starting at a dose of 0.6 mg with weekly 0.6 mg increments to 3.0 mg in adjunct to advice on a weight-reduction diet and physical exercise

Treatment:

Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml

Combination CPAP/Liraglutide

Experimental group

Description:

Combination of both interventions

Treatment:

Combination Product: Liraglutide and CPAP