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

The Effect of CPAP on Nocturnal Dipping in Normotensive Patients With Moderate-severe Obstructive Sleep Apnoea, a Multicentre Randomised Controlled Trial

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04938128

Enrollment

Registered

2021-06-24

Start date

2021-04-12

Completion date

2022-10-31

Last updated

2023-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Obstructive

Keywords

Continuous positive airway pressure, Non-dipper, Normotensive

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.

Interventions

DEVICECPAP

Gold standard treatment for obstructive sleep apnea. In this group, patients will be prescribed CPAP treatment according to local policy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Dipping status	3 months	Change in % dipping after 3 months of treatment with CPAP versus Control

Secondary

Measure	Time frame	Description
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
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

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026