SYNERGY OSA

Ki vehet részt

• AHI3a ≥15
• Provision of informed consent after the scope and nature of the study have been explained prior to any study specific procedures
• Able to speak, read and understand the local language and possess the ability to respond to questions, follow instructions, complete questionnaires, and comply with the study procedures
• Male or female gender and aged 18 to 75 years (both inclusive)

Ki nem vehet részt

• Planned surgery during the study period or major surgery within 6 months before first dose
• Drug-resistant hypertension (>140/90 mmHg in spite of at least ongoing treatment with at least three drugs)
• Patients with insufficiently treated hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg). If treated, patients must have been on the same dose of antihypertensive medication for at least 4 weeks prior to inclusion
• Change of antihypertensive medication within the last 4 weeks prior to the randomization visit (A patient may be re-screened after 4 weeks at the discretion of the investigator providing criteria for blood pressure treatment are fulfilled)
• Episode of major depression, bipolar disorder, or any other significant psychiatric disorder within the last 12 months prior to screening
• Myocardial infarction or coronary vessel intervention within the previous 6 months period or unstable angina pectoris
• Previously diagnosed or treated clinically significant cardiac arrhythmia
• A male patient who has not been vasectomized at least 6 months before screening and partners with a WOCBP must be willing to follow the contraceptive guidance provided (See Appendix C) during the treatment period and for at least 4 weeks after the last study drug administration
• History of actual suicidal behaviour or suicidal ideation of type 2 to 5 within one year prior to screening, or current suicidal ideation of any type (i.e., 1 to 5) as assessed by the Colombia Suicide Symptom-Rating Scale (C-SSRS) at screening
• Patients actively participating in any active weight loss treatment program including any weight loss medication (prescription or over the counter)
• Patients previously treated by uvulopalatopharyngoplastic surgery (UPPP) or any other type of surgery for OSA
• Any OSA treatment within the last 3 weeks prior to baseline
• Patients fulfilling criteria for a dominant central sleep apnea syndrome or dominant episodes with Cheyne Stokes respiration or other clinically significant sleep disorder including periodic limb movement disorder, restless leg syndrome, periodic limb movements arousal index (PLMAI)>15, parasomnia, or narcolepsy
• History of alcohol or drug abuse during the last year
• Any clinical condition that would result in deviation from clinical routine for fitting of an OAT, according to the investigators opinion
• Hypoventilation or hypoxemia due to COPD or other respiratory condition at the discretion of the investigator (pCO2 >6.5kPa)
• A female patient is eligible to participate if she is not pregnant, not breastfeeding, and if at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) (See Appendix C: Guidance for Contraception and Pregnancy testing) OR A WOCBP who agrees to follow the contraceptive guidance provided during the treatment period and for at least 4 weeks after the last dose of study drug
• Significant neurological or cognitive disorders including diagnosed dementia, Alzheimer’s disease, Parkinson´s disease, stroke, current epilepsy which, in the opinion of the investigator, might interfere with participation in the study
• Renal or hepatic failure defined as limiting according to the judgement of the investigator
• Type 1 diabetes or insulin treated type 2 diabetes or poorly controlled type 2 diabetes (HbA1c >53 mmol/mL or >7%)
• Acute porphyria or untreated hyperthyreosis
• An occupation designated as high risk or safety sensitive including handling complex machinery or professional drivers where there may be an increased risk for work or traffic accidents
• Patients currently involved in shiftwork