Obstructive Sleep ApnoeaNCT02417584
Efficacy of PAP Therapy on Blood Pressure
A study testing positive airway pressure (PAP) in people with Obstructive Sleep Apnoea, run by University of Crete at 1 site in Greece.
Trial summary
The aim of the study was to determine the long term effects of compliance with positive airway pressure therapy on blood pressure in both hypertensive and normotensive patients with obstructive sleep apnoea hypopnoea syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnoea
- What is being tested?
- positive airway pressure (PAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,168 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2009to May 2014
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- newly diagnosed OSAHS by polysomnography according to standard criteria
- no history of previous PAP therapy
- normotensive and hypertensive patients
- an above-elementary school education.
Who cannot join
- refusal to participate
- refusal of PAP therapy
- secondary hypertension
- central sleep apnea syndromes
- obesity hypoventilation syndrome
- restrictive ventilator syndromes
Show all 19Show fewer
- history of established cardiovascular disease
- severe congestive heart failure
- a history of life-threatening arrhythmias
- severe cardiomyopathy
- significant chronic kidney disease
- long-term oxygen therapy
- family or personal history of mental illness
- drug or alcohol abuse
- severe cognitive impairment
- concurrent oncological diseases
- need for chronic use of medication that may affect BP levels
- pregnancy
- history of narcolepsy or restless leg syndrome
Trial locations and contacts
1 site in 1 country.
Greece1 site
Sleep Disorders Center, Department of Thoracic Medicine, University of Crete,
Heraklion, 71110
About this study
Official title: The Role of Compliance With Positive Airway Pressure Use on Blood Pressure in Patients With Obstructive Sleep Apnea
The aim of the study was to determine the long term effects of compliance with positive airway pressure therapy on blood pressure in both hypertensive and normotensive patients with obstructive sleep apnoea hypopnoea syndrome.
Read the detailed description
Scientific data about the causal role of obstructive sleep apnoea hypopnoea syndrome (OSAHS) in the development of systemic hypertension and the effects of positive airway pressure (PAP) treatment on blood pressure (BP) control are continuously increasing; however they are controversial. We aimed to determine the long term effects of compliance with PAP therapy on BP in both hypertensive and normotensive patients with OSAHS.
- Conditions
- Obstructive Sleep Apnoea
- Being tested
- positive airway pressure (PAP)
- 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.
positive airway pressure (PAP)Device
Positive Airway Pressure (PAP) is a non-invasive machine providing air pressure f to prevent the collapse of the oropharyngeal walls and the obstruction of airflow during sleep, which occurs in obstructive sleep apnea hypopnea syndrome.
| Study group | Role | What they receive |
|---|---|---|
| positive airway pressure (PAP) | Experimental | Treatment with positive airway pressure (PAP) Receives: Device: positive airway pressure (PAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
drop in blood pressure
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApnoeaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Crete
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izolde Bouloukaki, University of Crete
- Investigators
- Sophia E Schiza, MD, PhD, Study chair, University of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417584
- Sponsor's protocol ID
- PAPBP-01
- Status last verified
- Apr 2015
- First submitted
- 11 Apr 2015
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Compliance With Positive Airway Pressure Use on Blood Pressure in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02417584
- Acronym / sponsor ID
- PAPBP-01
- Conditions
- Obstructive Sleep Apnoea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,168 participants (actual)
- Lead sponsor
- University of CreteUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Apr 2015 (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.
The aim of the study was to determine the long term effects of compliance with positive airway pressure therapy on blood pressure in both hypertensive and normotensive patients with obstructive sleep apnoea hypopnoea syndrome.
Detailed description
Scientific data about the causal role of obstructive sleep apnoea hypopnoea syndrome (OSAHS) in the development of systemic hypertension and the effects of positive airway pressure (PAP) treatment on blood pressure (BP) control are continuously increasing; however they are controversial. We aimed to determine the long term effects of compliance with PAP therapy on BP in both hypertensive and normotensive patients with OSAHS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| positive airway pressure (PAP) | Experimental | Device: positive airway pressure (PAP)Treatment with positive airway pressure (PAP) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- newly diagnosed OSAHS by polysomnography according to standard criteria
- no history of previous PAP therapy
- normotensive and hypertensive patients
- an above-elementary school education.
Key exclusion criteria (19 listed)
- refusal to participate
- refusal of PAP therapy
- secondary hypertension
- central sleep apnea syndromes
- obesity hypoventilation syndrome
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 |
|---|---|---|
| positive airway pressure (PAP)Positive Airway Pressure (PAP) is a non-invasive machine providing air pressure f to prevent the collapse of the oropharyngeal walls and the obstruction of airflow during sleep, which occurs in obstructive sleep apnea hypopnea syndrome. | Device | positive airway pressure (PAP) |
Primary outcome
drop in blood pressure
Time frame: two years
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 15 Apr 2015.
Related trials for Obstructive Sleep Apnoea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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DRonabinol Treatment of OSA
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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.
Sophia E Schiza, MD, PhD study chair
University of Crete
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positive airway pressure (PAP) in people with Obstructive Sleep Apnoea, run by University of Crete at 1 site in Greece.
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 19 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 15 Apr 2015. 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 Greece. 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?
drop in blood pressure (time frame: two years). 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 15 Apr 2015.