A Short Term Open, Randomized Cross-over Trial Exploring the Effect of Carbonic Anhydrase Inhibition by Acetazolamide on Sleep Apnea Associated Hypertension and Vascular Dysfunction
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Göteborg University
Age
18–75
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Provision of informed consent prior to any study specific procedures
Males 18 to 75 years
An Apnea-Hypopnea Index (AHI)\>15 and an Epworth Sleepiness Scale score (ESS)\>6 as verified by a PSG recording.
Patients with established hypertension (systolic/diastolic blood pressure \>= 160/95, either systolic or diastolic accounted for).
Clinically normal physical findings and laboratory values, as judged by the investigator
Body mass index \>= 35 kg/m2
You may not be if
Hypersensitivity to sulfonamides or acetazolamide-
Patients with ongoing medication with other sulphonamides or patients any specific antihypertensive treatment.
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity.
Subjects with a seizure disorder
Patients with clinically verified central sleep apnea
Clinically significant renal (serum creatinine \>2.0 mg/dL or \>130 micromol/L), neurological, metabolic (e.g. Type 1 or 2 diabetes), haematological or hepatic disease (ASAT or ALAT \>2 times the upper limit of normal).
Subjects with an occupational risk potentially exaggerated by daytime sleepiness such as handling complex machinery or professional driving
Myocardial infarction or coronary vessel intervention within the previous 6 months period.
Subjects with uncontrolled hypertension (defined as a diastolic blood pressure ≥110 mmHg and/or a systolic blood pressure ≥180 mmHg with or without medication).
Previously diagnosed or treated clinically significant cardiac arrhythmia
Clinically significant chronic pulmonary or gastrointestinal disease.
Clinical history of depression as judged by the investigator or other previous or present clinically significant psychiatric disease
Suspected or confirmed poor compliance
Alcohol or drug abuse during the last year.
Subjects with any other significant condition that, in the opinion of the investigator, could interfere with participation in the study.
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
Participation in another clinical study during the last 6 months.
Inability to understand and complete the questionnaires.
Clareo Health | A Short Term Open, Randomized Cross-over Trial Exploring the Effect of Carbonic Anhydrase Inhibition by Acetazolamide on Sleep Apnea Associated Hypertension and Vascular Dysfunction
