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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2022
  • participants needed
    100
  • sponsor
    St Vincent's University Hospital, Ireland
Updated on 1 July 2021

Summary

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.

Details
Condition Obstructive sleep apnea
Treatment CPAP
Clinical Study IdentifierNCT04938128
SponsorSt Vincent's University Hospital, Ireland
Last Modified on1 July 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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