Cardiovascular Effects After CPAP Withdrawal for Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Arterial Stiffness and Blood Pressure Changes After Continuous Positive Airway Pressure (CPAP) Withdrawal for Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329470
• Other study ID #: Dnr: 2010-329-31M
• Status: Completed
• Phase: N/A
• Start date: December 18, 2014
• Est. completion date: August 31, 2016

Study information

• Verified date: February 2023
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Cardiovascular Disease
• Cardiovascular Diseases
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Withdrawal of continuous positive airway pressure treatment
Withdrawal of continuous positive airway pressure treatment

Locations

Country	Name	City	State
Sweden	Dept of Respiratory Medicine	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial stiffness.	Arterial stiffness measured with Vicorder and pulse wave analysis	5 days
Primary	Systolic and diastolic blood pressure	24 hour blood pressure measurements	5 days
Secondary	Gender differences	Effect of gender on outcomes	5 days
Secondary	Effect on myocardial function	Brain natriuretic peptide	5 days
Secondary	Impact on apnea hypopnea index	apnea-hypopnea index	5 days
Secondary	Effect on oxygen saturation	Oxygen desaturation index	5 days
Secondary	Effect on catecholamines	measurements of urinary catecholamines during one day	5 days
Secondary	Effect on blood lipids in the form triglycerides	serum triglycerides	5 days
Secondary	Effect on blood lipids in the form of cholesterol	serum cholesterol	5 days
Secondary	Effect on systemic inflammation.	C reactive protein (CRP)	5 days
Secondary	Effect on glucose metabolism in the form of fasting glucose	Serum glucose obtained fasting in the morning	5 days
Secondary	Long-term effect on glucose metabolism	serum HbA1c	5 days
Secondary	Glucose metabolism in the form om Insulin levels	fasting serum insulin obtained in the morning.	5 days
Secondary	Effect on renal function	serum creatinine	5 days
Secondary	Effect on hemoglobin	serum hemoglobin	5 days
Secondary	Assessment of daytime sleepiness for a past period of time	Epworth sleepiness scale	5 days
Secondary	Daytime sleepiness assessed at a certain time point	Karolinska sleepiness scale	5 days
Secondary	Effect on lung volumes	Vital capacity	5 days
Secondary	Effect on airway obstructions	Forced vital capacity in one second	5 days
Secondary	Effect on airway inflammation	Exhaled nitric oxide test	5 days