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Cardiovascular Effects After CPAP Withdrawal for Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea, Cardiovascular Disease

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Withdrawal of continuous positive airway pressure treatment
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older,
  • given the written consent to participate in the study,
  • 2 months to 2 years of continuous positive airway pressure (CPAP) treatments with good compliance (mean CPAP use of >4 hours/night) during the last month before inclusion
  • moderate sleep apnea with Apnea Hypopnea Index >15 before treatment

Exclusion Criteria:

  • Apnea hypopnea index > 10 with CPAP treatment,
  • heart infarction within 3 months prior to study participation,
  • severe dementia,
  • determined by study personal having psychological or physical hinder to participate in the study

Sites / Locations

  • Dept of Respiratory Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

No device, n=50

Continue using device, continuous positive airway pressure treatment n=50

Arm Description

Withdrawal of device, continuous positive airway pressure treatment during 5 nights

Control group, Continue with device, continuous positive airway pressure treatment

Outcomes

Primary Outcome Measures

Arterial stiffness.
Arterial stiffness measured with Vicorder and pulse wave analysis
Systolic and diastolic blood pressure
24 hour blood pressure measurements

Secondary Outcome Measures

Gender differences
Effect of gender on outcomes
Effect on myocardial function
Brain natriuretic peptide
Impact on apnea hypopnea index
apnea-hypopnea index
Effect on oxygen saturation
Oxygen desaturation index
Effect on catecholamines
measurements of urinary catecholamines during one day
Effect on blood lipids in the form triglycerides
serum triglycerides
Effect on blood lipids in the form of cholesterol
serum cholesterol
Effect on systemic inflammation.
C reactive protein (CRP)
Effect on glucose metabolism in the form of fasting glucose
Serum glucose obtained fasting in the morning
Long-term effect on glucose metabolism
serum HbA1c
Glucose metabolism in the form om Insulin levels
fasting serum insulin obtained in the morning.
Effect on renal function
serum creatinine
Effect on hemoglobin
serum hemoglobin
Assessment of daytime sleepiness for a past period of time
Epworth sleepiness scale
Daytime sleepiness assessed at a certain time point
Karolinska sleepiness scale
Effect on lung volumes
Vital capacity
Effect on airway obstructions
Forced vital capacity in one second
Effect on airway inflammation
Exhaled nitric oxide test

Full Information

First Posted
December 12, 2014
Last Updated
February 28, 2023
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT02329470
Brief Title
Cardiovascular Effects After CPAP Withdrawal for Obstructive Sleep Apnea
Official Title
Arterial Stiffness and Blood Pressure Changes After Continuous Positive Airway Pressure (CPAP) Withdrawal for Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 18, 2014 (Actual)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
August 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Patients with obstructive sleep apnea run an increased risk of cardiovascular disease including hypertension. Continuous positive airway pressure (CPAP) is the first line of treatment. However, many patients skip CPAP for some nights. Aims: The primary aim was to investigate the cardiovascular effects of short-term CPAP withdrawal for five nights because of obstructive sleep apnea. Design: Randomized, parallel controlled trial Inclusion criteria: 100 patients with successful CPAP treatment for moderate to severe obstructive sleep apnea. Exclusion criteria: Dementia, heart infarction within 3 months, apnea hypopnea index > 10 with CPAP treatment. Randomization: 50 patients are randomized to sleep 5 days without CPAP and 50 patients to continue with CPAP treatment during the trial. Primary outcomes: Arterial stiffness, 24-hour blood pressure. Secondary outcomes: Effects of gender on outcome. Effects on brain natriuretic peptide, apnea-hypopnea index, oxygen desaturation-index, urine-catecholamines, blood lipids, C-reactive protein, glucose metabolism (S-glc, HBA1c), insulin resistance, serum creatinine, hemoglobin, daytime sleepiness (ESS, KSS), lung function (FVC, FEV1), airway inflammation (exhaled NO) Procedures: Sleep apnea investigation while patients are treated with CPAP for one night. Urinary samplings during the same night. They are also investigated with 24 h blood pressure measurements. Blood samples are taking fasting in the morning followed by measuring the arterial stiffness (Vicorder, Skidmore Medical UK) including pulse wave analysis using sphygmomanometer (Omron Japan). The same investigations are done at follow-up 5 days later where half of the patients have continued using CPAP treatment and half of them has slept without CPAP.
Detailed Description
Patients fulfilling inclusion criteria are invited to the trial after informed consent for baseline and follow-up investigations. Baseline investigations Day 1 Patients are given a questionnaire. They are given blood pressure monitoring, (ABPM Medical 90217 ambulatory blood pressure monitor, Spacelab) for 24 hours a starting at 8-9 AM. They are also given sleep apnea recorder (Embletta, X 10 system, Embla systems, ResMed) for ambulatory use during the following night, and a container for urinary sampling during the night (urine norepinephrine). Day 2 Fasting on arrival. Return of the 24-h blood pressure recorder, the sleep apnea recorder and the urine sampling container. Blood samples at 08.15 am after resting for 15 minutes. Arterial stiffness is measured using arterial pulse wave velocity, radial artery applanation tonometry and office blood pressure. After resting, the measurements starts at 8.30 AM in a room with a temperature of 24°C. Pulse wave velocity (Vicorder, Skidmore Medical, Bristol, UK) is measured in the supine position. The augmentation index is derived from pulse wave analysis obtained from radial artery applanation tonometry on the right arm (SphygmoCor, AtCor Medical, Sydney, Australia). Lung function and exhaled NO measurements, ECG. Breakfast at around 10.00 am. CPAP time counter check Patients are then randomized with a ration of 1:1 to continue with CPAP or not for the following 5 nights. Follow-up measurements Day 6 They are given blood pressure monitoring, (ABPM Medical 90217 ambulatory blood pressure monitor, Spacelab) for 24 hours a starting at 8-9 AM. They are also given sleep apnea recorder (Embletta, X 10 system, Embla systems, ResMed) for ambulatory use during the following night, and a container for urinary sampling during the night (urine norepinephrine). Day 7 Fasting on arrival. CPAP time counter check Return of the 24-h blood pressure recorder, the sleep apnea recorder and the urine sampling container. Blood samples at 08.15 am after resting for 15 minutes. Arterial stiffness is measured using arterial pulse wave velocity, radial artery applanation tonometry and office blood pressure. After resting, the measurements starts at 8.30 AM in a room with a temperature of 24°C. Pulse wave velocity (Vicorder, Skidmore Medical, Bristol, UK) is measured in the supine position. The augmentation index is derived from pulse wave analysis obtained from radial artery applanation tonometry on the right arm (SphygmoCor, AtCor Medical, Sydney, Australia). Lung function and exhaled NO measurements, ECG. Breakfast at around 10.00 am. Trials ends and patients are told to continue with CPAP as usual.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Cardiovascular Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No device, n=50
Arm Type
Experimental
Arm Description
Withdrawal of device, continuous positive airway pressure treatment during 5 nights
Arm Title
Continue using device, continuous positive airway pressure treatment n=50
Arm Type
No Intervention
Arm Description
Control group, Continue with device, continuous positive airway pressure treatment
Intervention Type
Procedure
Intervention Name(s)
Withdrawal of continuous positive airway pressure treatment
Intervention Description
Withdrawal of continuous positive airway pressure treatment
Primary Outcome Measure Information:
Title
Arterial stiffness.
Description
Arterial stiffness measured with Vicorder and pulse wave analysis
Time Frame
5 days
Title
Systolic and diastolic blood pressure
Description
24 hour blood pressure measurements
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Gender differences
Description
Effect of gender on outcomes
Time Frame
5 days
Title
Effect on myocardial function
Description
Brain natriuretic peptide
Time Frame
5 days
Title
Impact on apnea hypopnea index
Description
apnea-hypopnea index
Time Frame
5 days
Title
Effect on oxygen saturation
Description
Oxygen desaturation index
Time Frame
5 days
Title
Effect on catecholamines
Description
measurements of urinary catecholamines during one day
Time Frame
5 days
Title
Effect on blood lipids in the form triglycerides
Description
serum triglycerides
Time Frame
5 days
Title
Effect on blood lipids in the form of cholesterol
Description
serum cholesterol
Time Frame
5 days
Title
Effect on systemic inflammation.
Description
C reactive protein (CRP)
Time Frame
5 days
Title
Effect on glucose metabolism in the form of fasting glucose
Description
Serum glucose obtained fasting in the morning
Time Frame
5 days
Title
Long-term effect on glucose metabolism
Description
serum HbA1c
Time Frame
5 days
Title
Glucose metabolism in the form om Insulin levels
Description
fasting serum insulin obtained in the morning.
Time Frame
5 days
Title
Effect on renal function
Description
serum creatinine
Time Frame
5 days
Title
Effect on hemoglobin
Description
serum hemoglobin
Time Frame
5 days
Title
Assessment of daytime sleepiness for a past period of time
Description
Epworth sleepiness scale
Time Frame
5 days
Title
Daytime sleepiness assessed at a certain time point
Description
Karolinska sleepiness scale
Time Frame
5 days
Title
Effect on lung volumes
Description
Vital capacity
Time Frame
5 days
Title
Effect on airway obstructions
Description
Forced vital capacity in one second
Time Frame
5 days
Title
Effect on airway inflammation
Description
Exhaled nitric oxide test
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older, given the written consent to participate in the study, 2 months to 2 years of continuous positive airway pressure (CPAP) treatments with good compliance (mean CPAP use of >4 hours/night) during the last month before inclusion moderate sleep apnea with Apnea Hypopnea Index >15 before treatment Exclusion Criteria: Apnea hypopnea index > 10 with CPAP treatment, heart infarction within 3 months prior to study participation, severe dementia, determined by study personal having psychological or physical hinder to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl A Franklin, Prof, MD
Organizational Affiliation
umea University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carin Sahlin, PhD
Organizational Affiliation
Umea University
Official's Role
Study Director
Facility Information:
Facility Name
Dept of Respiratory Medicine
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden

12. IPD Sharing Statement

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Cardiovascular Effects After CPAP Withdrawal for Obstructive Sleep Apnea

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