Automate Detection of Sleep Apnea by ApneascanTM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to compare, three months after implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D), the apnea-hypopnea index (AHI) obtained from conventional in-lab NPSG/NPG (AHIPSG) with similar indices obtained from autoscoring algorithms of the ApneaScan™, an implantable impedance-based respiration sensor (AHIAS).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor

NCT03300037

Sleep Apnea, Obstructive

COMPLETED

ECG Derived Respiration for Automated Screening of Sleep Disordered Breathing in Chronic Heart Failure Patients

NCT02116686

Heart Failure Sleep Apnea Syndromes Polysomnography

COMPLETED

Suitability of Unobtrusive Bed Monitoring and Wrist-worn Heart Rate Monitor for Patient Monitoring

NCT03572751

Arrhythmia Hemorrhage Septic Shock +2 more

COMPLETED

Usability Evaluation - Reassure Respiration Rate Device: Home User Study

NCT02740517

Ease of Use

COMPLETED

Applying Artificial Intelligence to the 12 Lead ECG for the Diagnosis of Pulmonary Hypertension: an Observational Study

NCT05942859

Pulmonary Hypertension (Diagnosis)

ENROLLING_BY_INVITATION

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective, multi center, phase-IV with blinded analysis and central reading of polysomnography trial.

The study is performed in patients with a standard CRT-D or Implantable Cardioverter Defibrillator (ICD) devices indication. A total of 160 subjects will be recruited in France. The study duration is 03 months for each subject.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Apnea Arrhythmias

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Apneascan TM

autoscoring algorithms of the Apneascan TM compared to the polysomnography or polygraphy

Group Type OTHER

Apneascan TM

Intervention Type OTHER

Autoscoring algorithms with automatical detection of sleep apnea by the Apneascan TM

Polysomnography/polygraphy

Intervention Type DEVICE

1 night polysomnography/polygraphy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Apneascan TM

Autoscoring algorithms with automatical detection of sleep apnea by the Apneascan TM

Intervention Type OTHER

Polysomnography/polygraphy

1 night polysomnography/polygraphy

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male and female aged \> 18 years old
* Current ICD or CRT-D device-based guidelines indication (for primo-implantation)
* patients with optimal recommended medical therapy
* Patient willing and able of undergoing the device implant procedure
* Patient willing and able of undergoing the LATITUDE® NXT Patient Management system procedure
* Patient willing and able to complete the requirements of the study including the signature of the Informed Consent after full explanation of the study by the investigator prior to participation.

Exclusion Criteria

* Obstructive lung disease as defined by a FEV1/FVC less than 70%
* Obesity hypoventilation syndrome
* Treated sleep disorders breathing
* Cardiac surgery scheduled or strong likelihood of cardiac surgery 4 months after enrollment
* Life expectancy less than 1 year
* Inability to complete overnight PSG as defined by the protocol
* Patient who are or suspected to be pregnant and or plan to become pregnant
* Patient protected by the Law, under guardianship or curators
* Concomitant participation in an interventional biomedical research trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No