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

Primary Purpose

Sleep Apnea, Obstructive

Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
CPAP
Sponsored by
St Vincent's University Hospital, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Continuous positive airway pressure, Non-dipper, Normotensive

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St Vincent's University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CPAP treatment

Control

Arm Description

This group will receive CPAP treatment

This group will receive Diet and Lifestyle advice only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
June 16, 2021
Last Updated
June 16, 2021
Sponsor
St Vincent's University Hospital, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT04938128
Brief Title
Effect of CPAP vs Control on Nocturnal Dipping in Normotensive Patients With Obstructive Sleep Apnea
Official Title
The Effect of CPAP on Nocturnal Dipping in Normotensive Patients With Moderate-severe Obstructive Sleep Apnoea, a Multicentre Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Vincent's University Hospital, Ireland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Continuous positive airway pressure, Non-dipper, Normotensive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPAP treatment
Arm Type
Experimental
Arm Description
This group will receive CPAP treatment
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will receive Diet and Lifestyle advice only
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
Gold standard treatment for obstructive sleep apnea. In this group, patients will be prescribed CPAP treatment according to local policy.
Primary Outcome Measure Information:
Title
Change in Dipping status
Description
Change in % dipping after 3 months of treatment with CPAP versus Control
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in the mean 24-hour ambulatory blood pressure (BP)
Description
Change in mmHg in mean blood pressure from baseline to 12 weeks of treatment compared to control
Time Frame
3 months
Title
Change in blood pressure parameters
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silke Ryan, PhD, MD
Phone
+35312213702
Email
silke.ryan@ucd.ie
First Name & Middle Initial & Last Name or Official Title & Degree
Anne O' Mahony, MB BCh BAO
Phone
+35312214000
Email
anneomahony@svhg.ie
Facility Information:
Facility Name
St Vincent's University Hospital
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silke Ryan, PhD, MD
Phone
+35312213702
Email
silke.ryan@ucd.ie
First Name & Middle Initial & Last Name & Degree
Anne M O' Mahony, MB BCh BAO

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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