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

NCT ID: NCT04938128

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2022-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Apnea, Obstructive

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Continuous positive airway pressure Non-dipper Normotensive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CPAP treatment

This group will receive CPAP treatment

Group Type EXPERIMENTAL

CPAP

Intervention Type DEVICE

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

Control

This group will receive Diet and Lifestyle advice only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CPAP

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St Vincent's University Hospital, Ireland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Silke Ryan

Clinical Professor, Consultant in Respiratory and Sleep Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St Vincent's University Hospital

Dublin, , Ireland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ireland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RS21-008

Identifier Type: -

Identifier Source: org_study_id