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

December 15, 2023 updated by: Dr Silke Ryan, St Vincent's University Hospital, Ireland

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • St Vincent's University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPAP treatment
This group will receive CPAP treatment
Device: CPAP
Gold standard treatment for obstructive sleep apnea. In this group, patients will be prescribed CPAP treatment according to local policy.
No Intervention: Control
This group will receive Diet and Lifestyle advice only

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the mean 24-hour ambulatory blood pressure (BP)
Time Frame: 3 months
Change in mmHg in mean blood pressure from baseline to 12 weeks of treatment compared to control
3 months
Change in blood pressure parameters
Time Frame: 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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St Vincent's University Hospital, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Estimated)

July 31, 2022

Study Completion (Estimated)

October 31, 2022

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Actual)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS21-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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