Tirzepatide Versus Positive Airway Pressure for the Treatment of Obstructive Sleep Apnoea

Korábbi kezelés

• Driver occupation with excessive sleepiness (Epworth Sleepiness Scale >=16) or sleepiness-related motor vehicle accident or near accident within 12 months prior to enrolment
• Current or prior (≤3 months) OSA treatment with mechanical therapy (CPAP, MAS, Positional)
• Relative or absolute contraindication to CPAP including chronic cranial injury; recurrent pneumothorax; indication for oral-pharyngeal surgery, significant craniofacial abnormalities that may affect breathing, or are unwilling to use CPAP
• Any previous or planned surgery for OSA or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing (NB: Inclusion of a participant with more minor ear, nose or throat surgery (for example, deviated septum) will be at the investigator's discretion)
  • Glycaemia related criteria:
• Treatment with a GLP-1 receptor agonist within 90 days before screening
  • Obesity related criteria:
• A self-reported change in body weight >5 kg or >5% within 90 days before baseline
• Treatment with medication for the indication of obesity within 90 days before baseline and/or currently enrolled in a weight loss program
  • Other criteria:

Más betegség

• Respiratory failure including obesity hypoventilation syndrome (OHS) or daytime hypercapnia or moderate-severe chronic obstructive pulmonary disease (COPD) with FEV1/FVC ratio<0.7 and FEV1<80% predicted (GOLD criteria).
• Type 1 or type 2 diabetes mellitus

Laborértékek

• HbA1c ≥ 48 mmol/mol (6.5%) at screening
• Treatment with glucose-lowering agent(s) within 90 days before screening

Egyéb

• OSA or other respiratory related criteria:
• >50% respiratory events with Cheyne-Stokes Respiration (CSR) or Central Sleep Apnoea (CSA)
• Pregnancy/breast feeding or planning a pregnancy during the trial period
• Relative or absolute contraindication to tirzepatide including needle phobia

• Females and Males aged ≥ 18 years at the time of signing informed consent
• Moderate-severe OSA defined as an AHI ≥ 15/hr determined from a Type 1 or 2 sleep study conducted within the previous 12 months with a clinician recommendation for CPAP therapy.
• Moderate overweight or obesity defined as BMI ≥ 27 kg/m2. (Adjusted to BMI ≥ 25 kg/m2 for Asian populations as per WHO guidelines (WHO Expert Consultation (2004))
• No contraindication to tirzepatide use as per Australian Product Information
• Home internet access to enable cloud storage of SleepTracker-AI in-home BDI.
• Fluent English literacy and able to provide informed consent.