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

NCT04938128 | Withdrawn

• 1 other identifier: RS21-008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

Continuous positive airway pressure; Non-dipper; Normotensive

Outcome Measures

Primary Outcomes (1)

• Change in Dipping status

  Change in % dipping after 3 months of treatment with CPAP versus Control

  3 months

Secondary Outcomes (2)

• Change in the mean 24-hour ambulatory blood pressure (BP)

  3 months

• Change in blood pressure parameters

  3 months

Study Arms (2)

CPAP treatment

EXPERIMENTAL

This group will receive CPAP treatment

Device: CPAP

Control

NO INTERVENTION

This group will receive Diet and Lifestyle advice only

Interventions

CPAP DEVICE

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

CPAP treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St Vincent's University Hospital, Ireland: lead

Study Sites (1)

St Vincent's University Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Consultant in Respiratory and Sleep Medicine

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 24, 2021
• Study Start: April 12, 2021
• Primary Completion: July 31, 2022
• Study Completion: October 31, 2022
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)