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Completed

NCT Number: NCT02329470

Cardiovascular Effects After CPAP Withdrawal for Obstructive Sleep Apnea

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Respiratory Medicine

Umeå, 901 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Withdrawal of continuous positive airway pressure treatment

Procedure

Withdrawal of continuous positive airway pressure treatment

Primary outcomes

  1. Arterial stiffness.

    Time frame: 5 days

    Arterial stiffness measured with Vicorder and pulse wave analysis

  2. Systolic and diastolic blood pressure

    Time frame: 5 days

    24 hour blood pressure measurements

Secondary outcomes

  1. Gender differences

    Time frame: 5 days

    Effect of gender on outcomes

  2. Effect on myocardial function

    Time frame: 5 days

    Brain natriuretic peptide

  3. Impact on apnea hypopnea index

    Time frame: 5 days

    apnea-hypopnea index

  4. Effect on oxygen saturation

    Time frame: 5 days

    Oxygen desaturation index

  5. Effect on catecholamines

    Time frame: 5 days

    measurements of urinary catecholamines during one day

  6. Effect on blood lipids in the form triglycerides

    Time frame: 5 days

    serum triglycerides

  7. Effect on blood lipids in the form of cholesterol

    Time frame: 5 days

    serum cholesterol

  8. Effect on systemic inflammation.

    Time frame: 5 days

    C reactive protein (CRP)

  9. Effect on glucose metabolism in the form of fasting glucose

    Time frame: 5 days

    Serum glucose obtained fasting in the morning

  10. Long-term effect on glucose metabolism

    Time frame: 5 days

    serum HbA1c

  11. Glucose metabolism in the form om Insulin levels

    Time frame: 5 days

    fasting serum insulin obtained in the morning.

  12. Effect on renal function

    Time frame: 5 days

    serum creatinine

  13. Effect on hemoglobin

    Time frame: 5 days

    serum hemoglobin

  14. Assessment of daytime sleepiness for a past period of time

    Time frame: 5 days

    Epworth sleepiness scale

  15. Daytime sleepiness assessed at a certain time point

    Time frame: 5 days

    Karolinska sleepiness scale

  16. Effect on lung volumes

    Time frame: 5 days

    Vital capacity

  17. Effect on airway obstructions

    Time frame: 5 days

    Forced vital capacity in one second

  18. Effect on airway inflammation

    Time frame: 5 days

    Exhaled nitric oxide test

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 31, 2014
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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