obstructive sleep apnea related hypertension MedDRA version: 16.1 Level: LLT Classification code 10055577 Term: Obstructive sleep apnea syndrome System Organ Class: 100000004855
Conditions
Interventions
Trade Name: DIamox
Product Name: Diamox
Pharmaceutical Form: Tablet
INN or Proposed INN: Acetazolamide
CAS Number: 59-66-5
Other descriptive name: ACETAZOLAMIDE
Concentration unit: mg milligram(s)
Con
Sponsors
Göteborgs Universitet
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Males 18 to 75 years 3. An Apnea-Hypopnea Index (AHI)>15 and an Epworth Sleepiness Scale score (ESS)>6 as verified by a PSG recording. 4. Patients with established hypertension (systolic/diastolic blood pressure >= 160/95, either systolic or diastolic accounted for). 5. Clinically normal physical findings and laboratory values, as judged by the investigator 6. Body mass index >= 35 kg/m2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to sulfonamides or acetazolamide. 2. Patients with ongoing medication with other sulphonamides or patients any specific antihypertensive treatment. 3. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity. 4. Subjects with a seizure disorder. 5. Patients with clinically verified central sleep apnea. 6. Clinically significant renal (serum creatinine >2.0 mg/dL or >130 ?mol/L), neurological, metabolic (e.g. Type 1 or 2 diabetes), haematological or hepatic disease (ASAT or ALAT >2 times the upper limit of normal). 7. Subjects with an occupational risk potentially exaggerated by daytime sleepiness such as handling complex machinery or professional driving. 8. Unstable angina pectoris, unstable hypertension (or poorly controlled diabetes (HbA1C 7 mmoles/l). 9. Clinically significant congestive heart failure. 10. Myocardial infarction or coronary vessel intervention within the previous 6 months period. 11. Subjects with uncontrolled hypertension (defined as a diastolic blood pressure ?110 mmHg and/or a systolic blood pressure =180 mmHg with or without medication). 12. Previously diagnosed or treated clinically significant cardiac arrhythmia. 13. Clinically significant chronic pulmonary or gastrointestinal disease. 14. Clinical history of depression as judged by the investigator or other previous or present clinically significant psychiatric disease. 15. Suspected or confirmed poor compliance. 16. Alcohol or drug abuse during the last year. 17. Subjects with any other significant condition that, in the opinion of the investigator, could interfere with participation in the study. 18. Severe nocturnal hypoxia defined as more than 10 episodes with an oxygen desaturation exceeding 50% or signs of lacking resaturation between desaturations on previous recordings according to investigators judgment. 19. Participation in another clinical study during the last 6 months- 20. Inability to understand and complete the questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to use the enzyme carbonic anhydrase (CA) well known properties in order to create a physiological condition in order to explore and compare the efficacy of pharmacological CA inhibition on obstructive sleep apnea (OSA) related hypertension. Multiple aspects of vascular function and blood pressure control will be investigated in 12 male patients, using non-invasive methods, before and after short-term treatment of the carbonic anhydrase system (by acetazolamide (ACZ), continuous positive airway pressure (nCPAP) and nCPAP plus ACZ ;Secondary Objective: The secondary objective is to investigate the direct effect of CA inhibition on sleep disordered breathing.;Primary end point(s): The primary endpoint will be expressed in terms systolic and diastolic blood pressure (resting office, provoked office and 24 hour) as well as in various terms of vascular function (overnight vascular stiffness, heart rate variability and hypoxic vascular responsiveness) when comparing the acetazolamide to the nCPAP plus acetazolamide treatment regimen. ;Timepoint(s) of evaluation of this end point: The total study period is 10 weeks. Endpoint will be evaluated between baseline (0 weeks) and at end of each treatment period. Each treatment period is 2 weeks with a wash-out period between treatment regimens. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The change in sleep disordered breathing variables such as Apnea-Hypopnea index score (AHI), oxygen desaturation index (ODI), mean overnight oxygenation, and sleep quality, daytime sleepiness, patient-reported outcomes, and effects on metabolic markers when comparing treatment regimens.;Timepoint(s) of evaluation of this end point: The total study period is 10 weeks. Endpoint will be evaluated between baseline (0 weeks) and at end of each treatment period. Each treatment period is 2 weeks with a wash-out period between treatment regimens. | — |
Countries
Sweden
Contacts
Public ContactJan Hedner
Göteborgs Universitet
Outcome results
None listed