Apnea, SleepNCT03172806

Comparison of the New Algorithm of STOP-Bang in the Detection of Severe OSA Patients

An observational study of Apnea, Sleep, run by Astes at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this study was to compare the ability of clinical scores (P-SAP, OSA50, DES-OSA, STOP-Bang with former algorithm, and STOP-Bang with new algorithm). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Apnea, Sleep
What is being tested?: Polysomnography
How many people: 293 participants
Where: 1 siteBelgium
Study dates: 1 Aug 2016to 31 Jan 2018
How long will I take part?: 1 Month
Phase: Observational
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

Study population: All patients enrolling in the preanesthsia visit before elective surgery.

Who may be able to join

All patients in the preoperative anesthesia visit between 01/08/2016 and 31/12/2017

Who cannot join

Patient's refusal

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Clinique Saint-Luc de Bouge
Bouge, Namur, 5004

Other trials in Belgium

About this study

The aim of this study was to compare the ability of clinical scores (P-SAP, OSA50, DES-OSA, STOP-Bang with former algorithm, and STOP-Bang with new algorithm).

Read the detailed description

Severe OSA (Obstructive Sleep Apnea) patients are at higher risk of postoperative complications.

STOP-Bang has been proposed to detect OSA patients. It has been validated. New algorithm of STOP-Bang was proposed by the end of 2016. This aim of this study was to evaluate the ability of this new algorithm to detect severe OSA patients (patients with more than 30 events per hour). The new algorithm was also compared in this same ability with three others clinical score (P-SAP, OSA50 and DES-OSA).

Conditions: Apnea, Sleep
Being tested: Polysomnography
Medical subject headings: Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PolysomnographyDiagnostic test
To compare the ability of the clinical scores, all patients included in this study underwent a polysomnography.

Study groups in NCT03172806
Study group	Role	What they receive
Study Group		All patients included in the study. First: clinical scores were collected in all patients. Second: all patients underwent a polysomnography in order to compare this results with these of the clinical scores. Receives: Diagnostic Test: Polysomnography

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of results of clinical scores and results of polysomnography.
Comparison of the two results to determine the sensitivity and specificity of each clinical scores in comparison with polysmnography (the gold standard).
Measured: 1 night

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201631 Jan 2018

First posted1 Jun 2017
Study start1 Aug 2016
Primary completion31 Dec 2017
Study completion31 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Apnea, SleepStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 293 participants (actual)
Target duration: 1 Month

IDs, dates and publications

ClinicalTrials.gov ID: NCT03172806
Sponsor's protocol ID: NASB
Status last verified: Jun 2018
First submitted: 30 May 2017
Last updated: 19 Jun 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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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RecruitingPhase 3
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)
Apnea, Sleep Disorders

All Apnea, Sleep trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the New Algorithm of STOP-Bang in the Detection of Severe OSA Patients
ClinicalTrials.gov ID: NCT03172806
Acronym / sponsor ID: NASB
Conditions: Apnea, Sleep
Study type: Observational
Recruitment status: Completed
Enrolment: 293 participants (actual)
Lead sponsor: AstesUniversity, hospital or other
Study start: 1 Aug 2016 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 31 Jan 2018 (actual)
First posted: 1 Jun 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.

The aim of this study was to compare the ability of clinical scores (P-SAP, OSA50, DES-OSA, STOP-Bang with former algorithm, and STOP-Bang with new algorithm).

Detailed description

Severe OSA (Obstructive Sleep Apnea) patients are at higher risk of postoperative complications.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Month
Number of arms: 1

Arm	Type	Receives
Study Group	–	Diagnostic Test: PolysomnographyAll patients included in the study. First: clinical scores were collected in all patients. Second: all patients underwent a polysomnography in order to compare this results with these of the clinical scores.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients enrolling in the preanesthsia visit before elective surgery.

Key inclusion criteria (1 listed)

All patients in the preoperative anesthesia visit between 01/08/2016 and 31/12/2017

Key exclusion criteria (1 listed)

Patient's refusal

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
PolysomnographyTo compare the ability of the clinical scores, all patients included in this study underwent a polysomnography.	Diagnostic test	Study Group

Primary outcome

Comparison of results of clinical scores and results of polysomnography.
Time frame: 1 night
Comparison of the two results to determine the sensitivity and specificity of each clinical scores in comparison with polysmnography (the gold standard).

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 19 Jun 2018.
Individual participant dataSharing planned: No

Related trials for Apnea, Sleep

RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
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
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
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)
Apnea, Sleep Disorders

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.

Eric DEFLANDRE, MD, FCCP principal investigator

Astes

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Apnea, Sleep, run by Astes at 1 site in Belgium.

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 1 inclusion and 1 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 19 Jun 2018. 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 Belgium. 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?

Comparison of results of clinical scores and results of polysomnography. (time frame: 1 night). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03172806.

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 19 Jun 2018.