Sleep Apnea, ObstructiveNCT04938128
Effect of CPAP vs Control on Nocturnal Dipping in Normotensive Patients With Obstructive Sleep Apnea
A study testing CPAP in people with Sleep Apnea, Obstructive, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
Trial summary
This is an open-label, parallel, prospective, randomised control trial evaluating the effect of Continuous Positive airway pressure (CPAP), the standard treatment for obstructive sleep apnea (OSA) versus control (diet and lifestyle advice) on dipping status and blood pressure parameters in 100 non-dipper normotensive… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIreland
- Study dates
- 12 Apr 2021to 31 Oct 2022
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed moderate-severe OSA (by standard criteria)
- Absence of known hypertension and antihypertensive medication
- Office blood pressure <140/90mmHg
- Age 18 - 70 years
- Able to provide written, informed consent
Who cannot join
- Pregnancy
- Previous diagnosis of OSA or previous CPAP treatment
- Diagnosis of Diabetes Mellitus
- Active treatment for malignancy or severe psychiatric disorder
- History of cardiovascular disease or cerebrovascular disease
- Moderate or severe chronic kidney disease (CKD) defined as a eGFR of ≤ 44mL/min/1.73m2
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- Dipper on ABPM
- Morbid obesity, defined as BMI ≥40
- Professional drivers or drivers with a history of road-traffic accident due to sleepiness
- Severe excessive daytime sleepiness defined as Epworth sleepiness scale (ESS) >15
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of CPAP on Nocturnal Dipping in Normotensive Patients With Moderate-severe Obstructive Sleep Apnoea, a Multicentre Randomised Controlled Trial
This is an open-label, parallel, prospective, randomised control trial evaluating the effect of Continuous Positive airway pressure (CPAP), the standard treatment for obstructive sleep apnea (OSA) versus control (diet and lifestyle advice) on dipping status and blood pressure parameters in 100 non-dipper normotensive patients with moderate to severe obstructive sleep apnea and without established cardiovascular or metabolic disease.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- CPAP
- Keywords
- Continuous positive airway pressure, Non-dipper, Normotensive
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Gold standard treatment for obstructive sleep apnea. In this group, patients will be prescribed CPAP treatment according to local policy.
| Study group | Role | What they receive |
|---|---|---|
| CPAP treatment | Experimental | This group will receive CPAP treatment Receives: Device: CPAP |
| Control | No intervention | This group will receive Diet and Lifestyle advice only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dipping status
Change in % dipping after 3 months of treatment with CPAP versus Control
Measured: 3 months
Secondary outcomes (2)
Change in the mean 24-hour ambulatory blood pressure (BP)
Change in mmHg in mean blood pressure from baseline to 12 weeks of treatment compared to control
Measured: 3 months
Change in blood pressure parameters
Change in mmHg in blood pressure parameters including diurnal and nocturnal systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to 12 weeks of treatment compared to control
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start12 Apr 2021
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Why it stopped: Unable to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Vincent's University Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Silke Ryan, St Vincent's University Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938128
- Sponsor's protocol ID
- RS21-008
- Status last verified
- Dec 2023
- First submitted
- 16 Jun 2021
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of CPAP on Nocturnal Dipping in Normotensive Patients With Moderate-severe Obstructive Sleep Apnoea, a Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04938128
- Acronym / sponsor ID
- RS21-008
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Continuous positive airway pressure, Non-dipper, Normotensive
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St Vincent's University Hospital, IrelandUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 24 Jun 2021 (actual)
- 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.
This is an open-label, parallel, prospective, randomised control trial evaluating the effect of Continuous Positive airway pressure (CPAP), the standard treatment for obstructive sleep apnea (OSA) versus control (diet and lifestyle advice) on dipping status and blood pressure parameters in 100 non-dipper normotensive patients with moderate to severe obstructive sleep apnea and without established cardiovascular or metabolic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP treatment | Experimental | Device: CPAPThis group will receive CPAP treatment |
| Control | No intervention | –This group will receive Diet and Lifestyle advice only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed moderate-severe OSA (by standard criteria)
- Absence of known hypertension and antihypertensive medication
- Office blood pressure <140/90mmHg
- Age 18 - 70 years
- Able to provide written, informed consent
Key exclusion criteria (10 listed)
- Pregnancy
- Previous diagnosis of OSA or previous CPAP treatment
- Diagnosis of Diabetes Mellitus
- Active treatment for malignancy or severe psychiatric disorder
- History of cardiovascular disease or cerebrovascular disease
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 |
|---|---|---|
| CPAPGold standard treatment for obstructive sleep apnea. In this group, patients will be prescribed CPAP treatment according to local policy. | Device | CPAP treatment |
Primary outcome
Change in Dipping status
Time frame: 3 months
Change in % dipping after 3 months of treatment with CPAP versus Control
2 secondary outcomes
Change in the mean 24-hour ambulatory blood pressure (BP)
Time frame: 3 months
Change in blood pressure parameters
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Sleep Apnea, Obstructive, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
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 5 inclusion and 10 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: withdrawn, as of the sponsor's last update on 21 Dec 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 Ireland. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Dipping status (time frame: 3 months). 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 21 Dec 2023.