Status:
COMPLETED
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
Lead Sponsor:
Göteborg University
Conditions:
Obstructive Sleep Apnea
Sleep-Disordered Breathing
Eligibility:
MALE
18-75 years
Phase:
PHASE2
Brief Summary
This is a short term open, randomized cross over trial to explore and compare the efficacy of pharmacological carbonic anhydrase (CA) inhibition on obstructive sleep apnea (OSA) related hypertension. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Unstable angina pectoris, unstable hypertension (or poorly controlled diabetes (HbA1C \< 52 mmoles/mol, or fasting plasma glucose \>7 mmoles/l).
- Clinically significant congestive heart failure.
- 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.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02220803
Start Date
March 1 2014
End Date
August 1 2016
Last Update
August 16 2016
Active Locations (1)
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1
Center for Sleep and Vigilance disorders
Gothenburg, Västra Götaland County, Sweden, 40530