Effect of CPAP vs Control on Nocturnal Dipping in Normotensive Patients With Obstructive Sleep Apnea

St Vincent's University Hospital, Ireland

Status

Withdrawn

Conditions

Sleep Apnea, Obstructive

Treatments

Device: CPAP

Study type

Interventional

Funder types

Other

Identifiers

NCT04938128

RS21-008

Details and patient eligibility

About

This is an open-label, parallel, prospective, randomised control trial evaluating the effect of Continuous Positive airway pressure (CPAP), the standard treatment for obstructive sleep apnea (OSA) versus control (diet and lifestyle advice) on dipping status and blood pressure parameters in 100 non-dipper normotensive patients with moderate to severe obstructive sleep apnea and without established cardiovascular or metabolic disease.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Newly diagnosed moderate-severe OSA (by standard criteria)
Absence of known hypertension and antihypertensive medication
Office blood pressure <140/90mmHg
Age 18 - 70 years
Able to provide written, informed consent

Exclusion criteria

Pregnancy
Previous diagnosis of OSA or previous CPAP treatment
Diagnosis of Diabetes Mellitus
Active treatment for malignancy or severe psychiatric disorder
History of cardiovascular disease or cerebrovascular disease
Moderate or severe chronic kidney disease (CKD) defined as a eGFR of ≤ 44mL/min/1.73m2
Dipper on ABPM
Morbid obesity, defined as BMI ≥40
Professional drivers or drivers with a history of road-traffic accident due to sleepiness
Severe excessive daytime sleepiness defined as Epworth sleepiness scale (ESS) >15