Sleep Apnea, ObstructiveNCT03257488
Screening of Obstructive Sleep Apnea Syndrome in Patients With Resistant Systemic Arterial Hypertension: Pilot Study
A study testing type IV portable monitoring (Somnocheck micro Weinmann) in people with Sleep Apnea, Obstructive and Resistant Hypertension, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
This study evaluates the utility and reliability of Somnocheck micro Weinmann for obstructive sleep apnea syndrome (OSAS) screening in patients affected by resistant systemic arterial hypertension. Results are compared with a modified portable sleep apnea testing (type III portable monitoring: Somnocheck 2 Weinmann). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Resistant Hypertension
- What is being tested?
- type IV portable monitoring (Somnocheck micro Weinmann)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2015to Feb 2019
- 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
- Resistant Arterial Hypertension
- Patients must sign the informed consent
Who cannot join
- atrial fibrillation with haemodynamic instability
- congestive hearth failure,
- BMI>45 kg/m2,
- respiratory failure
- renal or liver failure,
- stroke,
Show all 12Show fewer
- implantable cardioverter-defibrillator (ICD),
- pacemaker (PM),
- previous diagnosis of OSAS,
- pregnancy,
- breastfeeding,
- patients must not be already enrolled in other clinical trial.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda ospedaliera policlinico Sant'Orsola-Malpighi
Bologna, 40138
Francesco Tavalazzi, medical, +300512143252, francesco.tavalazzi@aosp.bo.it
About this study
This study evaluates the utility and reliability of Somnocheck micro Weinmann for obstructive sleep apnea syndrome (OSAS) screening in patients affected by resistant systemic arterial hypertension. Results are compared with a modified portable sleep apnea testing (type III portable monitoring: Somnocheck 2 Weinmann).
Read the detailed description
OSAS is a syndrome characterized by the partial or total collapse of the high airways which determines snore, airflow limitation, hypopnea and apnea.These events cause desaturations, daytime sleepiness and an increased risk of cardio and cerebral vascular diseases.
OSAS's prevalence is estimated between 64-83% among patients affected by resistant arterial hypertension; therefore OSAS's screening is mandatory during the clinical work-up of these patients.
This study is a randomized, interventional, spontaneous, exploratory, cross-over and monocentric trial, which assesses the utility and reliability of the reduced cardio-respiratory monitoring (type IV portable monitoring: Somnocheck micro Weinmann) to estimate the prevalence of OSAS among patients affected by resistant systemic arterial hypertension. The results are compared with a complete cardio-respiratory monitoring (type III portable monitoring: Somnocheck 2 Weinmann).
- Conditions
- Sleep Apnea, Obstructive, Resistant Hypertension
- Being tested
- type IV portable monitoring (Somnocheck micro Weinmann)
- 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.
type IV portable monitoring (Somnocheck micro Weinmann)Device
Also called type III portable monitoring (Somnocheck 2 Weinmann)
Somnocheck micro Weinmann: a screening device for sleep disorders assessment. Somnocheck 2 Weinmann: a diagnostic device for obstructive sleep apnea.
| Study group | Role | What they receive |
|---|---|---|
| Screening device-Traditional device | Active comparator | The patients included in the A Group will be studied during the first night with the screening device (type IV portable monitoring Somnocheck micro Weinmann) and with the traditional one during the following night. Receives: Device: type IV portable monitoring (Somnocheck micro Weinmann) |
| Traditional device-Screening device | Active comparator | The patients included in the B Group will be studied during the first night with the traditional device and with the screening one (type IV portable monitoring Somnocheck micro Weinmann) during the following night. Receives: Device: type IV portable monitoring (Somnocheck micro Weinmann) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one.
Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one.
Measured: These two procedures must be done in the same patient within 5 days
Secondary outcomes (2)
Number of Participants with cardiovascular abnormalities 1
Number of Participants with cardiovascular abnormalities assessed by arterial blood pressure monitoring
Measured: Cardiovascular assessment must be done within 6 months before the sleep studies.
Number of Participants with cardiovascular abnormalities 2
Number of Participants with cardiovascular abnormalities assessed by ecocardiography
Measured: Cardiovascular assessment must be done within 6 months before the sleep studies.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study startApr 2015
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
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.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Tavalazzi, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257488
- Sponsor's protocol ID
- 163/2014/O/Disp
- Status last verified
- Jul 2017
- First submitted
- 10 Feb 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Obstructive Sleep Apnea Syndrome in Patients With Resistant Systemic Arterial Hypertension: Pilot Study
- ClinicalTrials.gov ID
- NCT03257488
- Acronym / sponsor ID
- 163/2014/O/Disp
- Conditions
- Sleep Apnea, Obstructive, Resistant Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 22 Aug 2017 (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 study evaluates the utility and reliability of Somnocheck micro Weinmann for obstructive sleep apnea syndrome (OSAS) screening in patients affected by resistant systemic arterial hypertension. Results are compared with a modified portable sleep apnea testing (type III portable monitoring: Somnocheck 2 Weinmann).
Detailed description
OSAS is a syndrome characterized by the partial or total collapse of the high airways which determines snore, airflow limitation, hypopnea and apnea.These events cause desaturations, daytime sleepiness and an increased risk of cardio and cerebral vascular diseases.
OSAS's prevalence is estimated between 64-83% among patients affected by resistant arterial hypertension; therefore OSAS's screening is mandatory during the clinical work-up of these patients.
This study is a randomized, interventional, spontaneous, exploratory, cross-over and monocentric trial, which assesses the utility and reliability of the reduced cardio-respiratory monitoring (type IV portable monitoring: Somnocheck micro Weinmann) to estimate the prevalence of OSAS among patients affected by resistant systemic arterial hypertension. The results are compared with a complete cardio-respiratory monitoring (type III portable monitoring: Somnocheck 2 Weinmann).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening device-Traditional device | Active comparator | Device: type IV portable monitoring (Somnocheck micro Weinmann)The patients included in the A Group will be studied during the first night with the screening device (type IV portable monitoring Somnocheck micro Weinmann) and with the traditional one during the following night. |
| Traditional device-Screening device | Active comparator | Device: type IV portable monitoring (Somnocheck micro Weinmann)The patients included in the B Group will be studied during the first night with the traditional device and with the screening one (type IV portable monitoring Somnocheck micro Weinmann) during the following night. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Resistant Arterial Hypertension
- Patients must sign the informed consent
Key exclusion criteria (12 listed)
- atrial fibrillation with haemodynamic instability
- congestive hearth failure,
- BMI>45 kg/m2,
- respiratory failure
- renal or liver failure,
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 |
|---|---|---|
| type IV portable monitoring (Somnocheck micro Weinmann)Also: type III portable monitoring (Somnocheck 2 Weinmann)Somnocheck micro Weinmann: a screening device for sleep disorders assessment. Somnocheck 2 Weinmann: a diagnostic device for obstructive sleep apnea. | Device | Screening device-Traditional device, Traditional device-Screening device |
Primary outcome
Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one.
Time frame: These two procedures must be done in the same patient within 5 days
Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one.
2 secondary outcomes
Number of Participants with cardiovascular abnormalities 1
Time frame: Cardiovascular assessment must be done within 6 months before the sleep studies.
Number of Participants with cardiovascular abnormalities 2
Time frame: Cardiovascular assessment must be done within 6 months before the sleep studies.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing type IV portable monitoring (Somnocheck micro Weinmann) in people with Sleep Apnea, Obstructive and Resistant Hypertension, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 22 Aug 2017. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Tavalazzi, Medical (+390512143253, francesco.tavalazzi@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one. (time frame: These two procedures must be done in the same patient within 5 days). 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 22 Aug 2017.