Sleep Apnea, ObstructiveNCT02055027

Adherence to Continuous Positive Airway Pressure Among Obstructive Sleep Apnoea Patients.

An observational study of Sleep Apnea, Obstructive, 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

Prospective study designed to identify factors that would predict patient adherence to CPAP (Continuous Positive Airway Pressure) therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sleep Apnea, Obstructive
What is being tested?: Comparison between groups
How many people: 90 participants
Where: 1 siteBelgium
Study dates: Feb 2008to Apr 2008
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: Sleep Study Center

Who may be able to join

Adults (> 18 patients)
All patients under CPAP (Continuous Positive Airway Pressure) therapy coming for annual visit in the Sart-Tilman Sleep Study Center

Who cannot join

Patient refusal

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Centre Hospitalier Universitaire (CHU) Sart-Tilman
Liège, Liege, 4000

Other trials in Belgium

About this study

Official title: Adherence to Continuous Positive Airway Pressure Among Obstructive Sleep Apnoea Patients. An Anaesthetic Algorithmic Approach to Prevent Postoperative Complications.

Prospective study designed to identify factors that would predict patient adherence to CPAP (Continuous Positive Airway Pressure) therapy.

Read the detailed description

Prospective study designed to identify factors that would predict patient adherence to CPAP therapy.

Comparison between data recorded among patients and the data of the CPAP microchip.

Conditions: Sleep Apnea, Obstructive
Being tested: Comparison between groups
Keywords: Sleep Apnea, Obstructive, Continuous Positive Airway Pressure, Perioperative Period
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.

Comparison between groupsOther
Comparison between the two groups (adherent and non-adherent patients) in order to discover criteria of non-adherence

Study groups in NCT02055027
Study group	Role	What they receive
Adherent Patients		Comparison between groups Receives: Other: Comparison between groups
Non-adherent patients		Comparison between groups Receives: Other: Comparison between groups

What is being measured

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

Number of hours of CPAP use by night
Analyse of the data recorded by the CPAP microchip in order to assess the adherent or non-adherent status to the patient (adherent: CPAP use > 4 hours per night, non-adherent: less than 4 hours)
Measured: Baseline

Secondary outcomes (1)

Lickert's scale to assess criteria of non-adherence
Evaluation of 72 criteria by a Lickert's scale in order to assess characteristics associated with non-adherence to CPAP therapy
Measured: Baseline

Timeline

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

Feb 2008Apr 2008

First posted4 Feb 2014 (estimated)
Study startFeb 2008
Primary completionMar 2008
Study completionApr 2008

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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02055027
Sponsor's protocol ID: ASTES-NCPAP
Status last verified: Feb 2014
First submitted: 3 Feb 2014
Last updated: 4 Feb 2014
Results posted: No
Data monitoring committee: 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

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
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
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Sleep Apnea, Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adherence to Continuous Positive Airway Pressure Among Obstructive Sleep Apnoea Patients. An Anaesthetic Algorithmic Approach to Prevent Postoperative Complications.
ClinicalTrials.gov ID: NCT02055027
Acronym / sponsor ID: ASTES-NCPAP
Conditions: Sleep Apnea, Obstructive
Keywords: Sleep Apnea, Obstructive, Continuous Positive Airway Pressure, Perioperative Period
Study type: Observational
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: AstesUniversity, hospital or other
Study start: Feb 2008
Primary completion: Mar 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 4 Feb 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.

Prospective study designed to identify factors that would predict patient adherence to CPAP (Continuous Positive Airway Pressure) therapy.

Detailed description

Prospective study designed to identify factors that would predict patient adherence to CPAP therapy.

Comparison between data recorded among patients and the data of the CPAP microchip.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Adherent Patients	–	Other: Comparison between groupsComparison between groups
Non-adherent patients	–	Other: Comparison between groupsComparison between groups

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Sleep Study Center

Key inclusion criteria (2 listed)

Adults (> 18 patients)
All patients under CPAP (Continuous Positive Airway Pressure) therapy coming for annual visit in the Sart-Tilman Sleep Study Center

Key exclusion criteria (1 listed)

Patient 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
Comparison between groupsComparison between the two groups (adherent and non-adherent patients) in order to discover criteria of non-adherence	Other	Adherent Patients, Non-adherent patients

Primary outcome

Number of hours of CPAP use by night
Time frame: Baseline
Analyse of the data recorded by the CPAP microchip in order to assess the adherent or non-adherent status to the patient (adherent: CPAP use > 4 hours per night, non-adherent: less than 4 hours)

1 secondary outcome

Lickert's scale to assess criteria of non-adherence
Time frame: Baseline

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 4 Feb 2014.

Related trials for Sleep Apnea, Obstructive

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
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
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

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 Sleep Apnea, Obstructive, 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 2 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 4 Feb 2014. 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?

Number of hours of CPAP use by night (time frame: Baseline). 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 NCT02055027.

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 4 Feb 2014.