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

Not Applicable

Withdrawn

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: CPAP

• Registration Number: NCT04938128
• Lead Sponsor: St Vincent's University Hospital, Ireland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-12
• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-16
• Study First Posted: 2021-06-24
• Primary Completion: 2022-07-31
• Study Completion: 2022-10-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP treatment	CPAP	This group will receive CPAP treatment

Primary Outcome Measures

Name	Time	Method
Change in Dipping status	3 months	Change in % dipping after 3 months of treatment with CPAP versus Control

Secondary Outcome Measures

Name	Time	Method
Change in blood pressure parameters	3 months	Change in mmHg in blood pressure parameters including diurnal and nocturnal systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to 12 weeks of treatment compared to control
Change in the mean 24-hour ambulatory blood pressure (BP)	3 months	Change in mmHg in mean blood pressure from baseline to 12 weeks of treatment compared to control

Trial Locations

Locations (1)

St Vincent's University Hospital; 🇮🇪 Dublin, Ireland