Treatment of OSA Associated Hypertension With Nebivolol or Hydrochlorothiazide

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients who have obstructive sleep apnea (OSA) frequently stop breathing while they sleep. They often develop high blood pressure. We are not sure what drug is best to treat the high blood pressure. This study will give the patients nebivolol or hydrochlorothiazide (HCTZ) for 6 weeks after 2 weeks of placebo. The blood pressure response will be evaluated by 24 hour monitoring.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Treatments: Hydrochlorothiazide; Nebivolol

Criteria

Inclusion Criteria:

• Patients ranging from 20 - 80 years

• Body mass index (BMI) of 20-38 to include the typical obese OSA patients

• Hypertension with blood pressures > 140/90 but less than 180/105 mmHg.

• Apnea-hypopnea index above 10

Exclusion Criteria:

• Receiving sleep medicines (including heavy alcohol use) or drugs with adverse interactions with study medication.

• Women who have premenstrual syndrome, or those who are pregnant or capable of pregnancy and unwilling to use effective non-hormonal contraception

• Shift workers or have symptoms of narcolepsy, restless legs syndrome or insomnia, in order to minimize confounding effects of other sleep disorders

• Have apneas which are primarily central

• Have sleep fragmentation caused by syndromes such as chronic pain or movement disorders

• Have diseases such as asthma or chronic obstructive pulmonary disease that compromises respiration.

• Have known coronary or cerebral vascular disease, history of arrhythmias, cardiomyopathy, history of psychosis, current alcohol or drug abuse.

• Have any contraindications to any study materials, such as heart block.

• Have secondary hypertension

• Have creatinine levels above 2.5 mg %, more than 1+ proteinuria by dipstick, hematuria or electrolyte disorders.