Obstructive Sleep ApneaNCT02329470
Cardiovascular Effects After CPAP Withdrawal for Obstructive Sleep Apnea
A study testing Withdrawal of continuous positive airway pressure treatment in people with Obstructive Sleep Apnea and Cardiovascular Disease, run by Umeå University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Cardiovascular Disease
- What is being tested?
- Withdrawal of continuous positive airway pressure treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 18 Dec 2014to 31 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arterial Stiffness and Blood Pressure Changes After Continuous Positive Airway Pressure (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.
Read more
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Cardiovascular Disease
- Being tested
- Withdrawal of continuous positive airway pressure treatment
- Medical subject headings
- Sleep Apnea, Obstructive, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withdrawal of continuous positive airway pressure treatmentProcedure or surgery
Withdrawal of continuous positive airway pressure treatment
| Study group | Role | What they receive |
|---|---|---|
| No device, n=50 | Experimental | Withdrawal of device, continuous positive airway pressure treatment during 5 nights Receives: Procedure: Withdrawal of continuous positive airway pressure treatment |
| Continue using device, continuous positive airway pressure treatment n=50 | No intervention | Control group, Continue with device, continuous positive airway pressure treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness.
Arterial stiffness measured with Vicorder and pulse wave analysis
Measured: 5 days
Systolic and diastolic blood pressure
24 hour blood pressure measurements
Measured: 5 days
Secondary outcomes (18)
Gender differences
Effect of gender on outcomes
Measured: 5 days
Effect on myocardial function
Brain natriuretic peptide
Measured: 5 days
Impact on apnea hypopnea index
apnea-hypopnea index
Measured: 5 days
Effect on oxygen saturation
Oxygen desaturation index
Measured: 5 days
Effect on catecholamines
measurements of urinary catecholamines during one day
Measured: 5 days
Effect on blood lipids in the form triglycerides
serum triglycerides
Measured: 5 days
Effect on blood lipids in the form of cholesterol
serum cholesterol
Measured: 5 days
Effect on systemic inflammation.
C reactive protein (CRP)
Measured: 5 days
Effect on glucose metabolism in the form of fasting glucose
Serum glucose obtained fasting in the morning
Measured: 5 days
Long-term effect on glucose metabolism
serum HbA1c
Measured: 5 days
Glucose metabolism in the form om Insulin levels
fasting serum insulin obtained in the morning.
Measured: 5 days
Effect on renal function
serum creatinine
Measured: 5 days
Effect on hemoglobin
serum hemoglobin
Measured: 5 days
Assessment of daytime sleepiness for a past period of time
Epworth sleepiness scale
Measured: 5 days
Daytime sleepiness assessed at a certain time point
Karolinska sleepiness scale
Measured: 5 days
Effect on lung volumes
Vital capacity
Measured: 5 days
Effect on airway obstructions
Forced vital capacity in one second
Measured: 5 days
Effect on airway inflammation
Exhaled nitric oxide test
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study start18 Dec 2014
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl A Franklin, Umeå University
- Investigators
- Karl A Franklin, Prof, MD, Principal investigator, umea UniversityCarin Sahlin, PhD, Study director, Umea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329470
- Sponsor's protocol ID
- Dnr: 2010-329-31M
- Status last verified
- Feb 2023
- First submitted
- 12 Dec 2014
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Stiffness and Blood Pressure Changes After Continuous Positive Airway Pressure (CPAP) Withdrawal for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02329470
- Acronym / sponsor ID
- Dnr: 2010-329-31M
- Conditions
- Obstructive Sleep Apnea, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 18 Dec 2014 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No device, n=50 | Experimental | Procedure: Withdrawal of continuous positive airway pressure treatmentWithdrawal of device, continuous positive airway pressure treatment during 5 nights |
| Continue using device, continuous positive airway pressure treatment n=50 | No intervention | –Control group, Continue with device, continuous positive airway pressure treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Withdrawal of continuous positive airway pressure treatmentWithdrawal of continuous positive airway pressure treatment | Procedure or surgery | No device, n=50 |
Primary outcome
Arterial stiffness.
Time frame: 5 days
Arterial stiffness measured with Vicorder and pulse wave analysis
Systolic and diastolic blood pressure
Time frame: 5 days
24 hour blood pressure measurements
18 secondary outcomes
Gender differences
Time frame: 5 days
Effect on myocardial function
Time frame: 5 days
Impact on apnea hypopnea index
Time frame: 5 days
Effect on oxygen saturation
Time frame: 5 days
Effect on catecholamines
Time frame: 5 days
Effect on blood lipids in the form triglycerides
Time frame: 5 days
Effect on blood lipids in the form of cholesterol
Time frame: 5 days
Effect on systemic inflammation.
Time frame: 5 days
Effect on glucose metabolism in the form of fasting glucose
Time frame: 5 days
Long-term effect on glucose metabolism
Time frame: 5 days
Glucose metabolism in the form om Insulin levels
Time frame: 5 days
Effect on renal function
Time frame: 5 days
Effect on hemoglobin
Time frame: 5 days
Assessment of daytime sleepiness for a past period of time
Time frame: 5 days
Daytime sleepiness assessed at a certain time point
Time frame: 5 days
Effect on lung volumes
Time frame: 5 days
Effect on airway obstructions
Time frame: 5 days
Effect on airway inflammation
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl A Franklin, Prof, MD principal investigator
umea University
Carin Sahlin, PhD study director
Umea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Withdrawal of continuous positive airway pressure treatment in people with Obstructive Sleep Apnea and Cardiovascular Disease, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial stiffness. (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.