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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04938128
• Other study ID #: RS21-008
• Status: Withdrawn
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: December 2023
• Source: St Vincent's University Hospital, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Ireland	St Vincent's University Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
St Vincent's University Hospital, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Dipping status	Change in % dipping after 3 months of treatment with CPAP versus Control	3 months
Secondary	Change in the mean 24-hour ambulatory blood pressure (BP)	Change in mmHg in mean blood pressure from baseline to 12 weeks of treatment compared to control	3 months
Secondary	Change in blood pressure parameters	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