SULTIAME for Obstructive sleep apnea|Obstructive sleep apnea syndrome

Inclusion criteria

• {"criterion_text":"- AHI3a ≥15"}
• {"criterion_text":"- Provision of informed consent after the scope and nature of the study have been explained prior to any study specific procedures."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Male or female gender and aged 18 to 75 years (both inclusive)."}

Exclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Acute porphyria or untreated hyperthyreosis"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients currently involved in shiftwork"}
• {"criterion_text":"- Planned surgery during the study period or major surgery within 6 months before first dose"}
• {"criterion_text":"- History of alcohol or drug abuse during the last year"}
• {"criterion_text":"- Any clinical condition that would result in deviation from clinical routine for fitting of an OAT, according to the investigators opinion"}
• {"criterion_text":"- Hypoventilation or hypoxemia due to COPD or other respiratory condition at the discretion of the investigator (pCO2 >6.5kPa)"}
• {"criterion_text":"- Drug-resistant hypertension (>140/90 mmHg in spite of at least ongoing treatment with at least three drugs)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Episode of major depression, bipolar disorder, or any other significant psychiatric disorder within the last 12 months prior to screening"}
• {"criterion_text":"- Myocardial infarction or coronary vessel intervention within the previous 6 months period or unstable angina pectoris"}
• {"criterion_text":"- Previously diagnosed or treated clinically significant cardiac arrhythmia"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Renal or hepatic failure defined as limiting according to the judgement of the investigator"}
• {"criterion_text":"- Type 1 diabetes or insulin treated type 2 diabetes or poorly controlled type 2 diabetes (HbA1c >53 mmol/mL or >7%)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients actively participating in any active weight loss treatment program including any weight loss medication (prescription or over the counter)"}
• {"criterion_text":"- Patients previously treated by uvulopalatopharyngoplastic surgery (UPPP) or any other type of surgery for OSA"}
• {"criterion_text":"- Any OSA treatment within the last 3 weeks prior to baseline"}

Primary endpoints

• {"endpoint_text":"- Reduction of the apnea/hypopnea index (AHI3a), in patients with an insufficient (AHI3a ≥15) therapeutic effect of an OAT, after STM 200 mg vs. placebo in a 2 week cross-over protocol","definition_or_measurement_approach":"Comparison of AHI3a (apnea/hypopnea index) after STM 200 mg versus placebo in a 2-week cross-over protocol (AHI3a metric as stated)."}

Secondary endpoints

• {"endpoint_text":"- Change in other OSA-related variables (AHI4), mean overnight SpO2, minimum SpO2, oxygen desaturation index 4% and hypoxic burden) as well as objective measures of sleep (sleep stages, total sleep time, arousal index, sleep efficacy) assessed by polysomnography (PSG) in patients with an insufficient therapeutic effect of an OAT after adding STM vs. placebo for 2 weeks in a cross-over protocol.","definition_or_measurement_approach":"Objective sleep measures and oxygenation variables assessed by polysomnography (PSG) and oxygen saturation metrics (mean overnight SpO2, minimum SpO2, ODI4%, hypoxic burden)."}
• {"endpoint_text":"- Exploratory endpoints including change from baseline and cross-over comparison. Effect of STM relative to placebo with respect to:","definition_or_measurement_approach":"Exploratory change-from-baseline and cross-over comparisons versus placebo; specific measures detailed in subsequent endpoints."}
• {"endpoint_text":"- •\tQuestionnaires on daytime functioning (ESS, FOSQ, CGI-S, CGI-I, PGI-S, SF-36, PGI-I, and C-SSRS) such as sleepiness, wellbeing, mood, and measures of quality of life under the dosing circumstances outlined above.","definition_or_measurement_approach":"Patient-reported outcome questionnaires (ESS, FOSQ, CGI-S, CGI-I, PGI-S, SF-36, PGI-I, C-SSRS) to assess daytime functioning, sleepiness, wellbeing, mood, and quality of life."}
• {"endpoint_text":"- •\tOther PSG variables (NREM AHI, REM AHI, supine AHI, RERA, EEG)","definition_or_measurement_approach":"Polysomnography-derived variables including NREM AHI, REM AHI, supine AHI, RERA and EEG metrics."}
• {"endpoint_text":"- •\tEffect on potential biomarkers of OSA including change in whole blood carbonic anhydrase (CA) activity, venous blood gases, concentration of carbonic anhydrase isoenzyme IX (CA-IX), circulating markers of hypoxemia including HIF-1a or phenotypic characteristics of upper airway function and stability during sleep under the dosing circumstances.","definition_or_measurement_approach":"Laboratory assessments: whole blood CA activity, venous blood gases, CA-IX concentration, circulating hypoxemia markers (e.g. HIF-1a) and phenotypic airway function measures."}
• {"endpoint_text":"- •\tInfluence of conventional comorbidities in OSA, such as BMI.","definition_or_measurement_approach":"Assessment of effect modification by conventional comorbidities (e.g., BMI) on outcomes."}
• {"endpoint_text":"- •\tChange in vital signs and biochemical markers including blood pressure, glycemic control and lipids.","definition_or_measurement_approach":"Clinical vital sign measurements and biochemical laboratory markers (blood pressure, glycemic control measures, lipid profile)."}

Denmark

Latest Decision Or Authorization Date

23-09-2024

Number Of Sites

1

Number Of Participants

15

Sweden

Latest Decision Or Authorization Date

24-09-2024

Number Of Sites

1

Number Of Participants

35

Primary sponsor

Full Name

Vaestra Goetalandsregionen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"Desitin Arzneimittel GmbH","duties_or_roles":"Monetary support","organisation_type":""}