NCT02329470

Cardiovascular Effects After CPAP Withdrawal for Obstructive Sleep Apnea

Completed NA Last updated 3 March 2023

What this trial tests

NA trial testing Withdrawal of continuous positive airway pressure treatment in Obstructive Sleep Apnea in 100 participants. Completed in 31 August 2016.

Timeline

18 December 2014

Primary endpoint
31 August 2016

31 August 2016

Quick facts

Lead sponsor	Umeå University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	18 December 2014
Primary completion	31 August 2016
Estimated completion	31 August 2016
Sites	1 location across Sweden

Drugs / interventions tested

• Withdrawal of continuous positive airway pressure treatment

Conditions studied

• Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
• Cardiovascular Disease — all drugs for Cardiovascular Disease →

Sponsor

Umeå University

Who can join

18 and older, any sex, with Obstructive Sleep Apnea or Cardiovascular Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cardiovascular effects after five nights without continuous positive airway pressure for obstructive sleep apnea: a randomized controlled trial.
   Sahlin C, Hedström M, Claesson M, Lindberg E, et al · · 2025 · PMID 40105199 · DOI 10.1097/hjh.0000000000003990