MedDataX Logo

PErsonalized and Adaptive Kinesthetic stImulation Therapy, Based on Cardio-respiratory Holter moNitoring, for Sleep Apnea syndrOmes

NCT ID: NCT02789748

Last Updated: 2017-10-05

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

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-10-02

Brief Summary

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

This study aims at quantifying the performance of kinesthetic stimulation to reduce the burden of obstructive sleep apneas and hypopneas.

Detailed Description

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

Severe sleep apnea patients will undergo two polysomnographies (PSG), one with kinesthetic stimulation triggered on the detection of apneas and hypopneas (treated night ) and the other without kinesthetic stimulation (non-treated night ). Comparison of apnea and hypopnea indices (AHI) and of oxygen saturation between the treated and non-treated night will be taken as indicators to quantify the performance of this potential new therapy.

Conditions

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

Obstructive Sleep Apnea Syndrome

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

Treatment ON

Kinesthetic stimulation administered during one night

Group Type EXPERIMENTAL

Kinesthetic stimulation

Intervention Type DEVICE

Activation of mechanoreceptors by vibration bursts

Treatment OFF

NO kinesthetic stimulation administered during one night

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Kinesthetic stimulation

Activation of mechanoreceptors by vibration bursts

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

Patients who meet all the following criteria at the time of enrollment may be included:

* Man or woman aged more than 18 years old.
* Patient with severe obstructive apnea syndrome diagnosed on polysomnography or polygraphy performed less than 6 months ago with (AHI \> 30/h and 80% of obstructive events) and (ODI 4% \> 20 or time with SaO2 below 90% \> 5%).
* Patient free from continuous positive airway pressure (CPAP) treatment or any other SAS treatment for at least 3 months
* Patient with no psychrotropic medication or stable psychotropic medication since the diagnostic polysomnography or polygraphy examination
* Patient was informed and has signed the informed consent

Exclusion Criteria

Patients who meet any one of these criteria will be excluded from the study:

* Patients sleeping less than 4 hours per night
* Patients suffering from respiratory failure, such as chronic obstructive pulmonary disease (COPD), pneumonia, pulmonary edema, pulmonary fibrosis, asthma, pulmonary arterial hypertension.
* Patients developing periodic breathing or Cheyne Stokes respiration
* Obese patient (BMI\>35kg/m2)
* Patient with autonomic dysfunction (symptoms include orthostatic hypotension, exercise intolerance, sweating abnormalities, digestion difficulties, urinary problems, vision problems) as complication of diabetes, Parkinson's disease or other primary pathologies.
* Patient suffering from restless leg syndrome or periodic leg movement (PLM) not related to obstructive sleep apnea, i.e. PLM index \> 15/h excluding movements linked to respiratory events.
* Patient suffering from positional sleep apnea syndrome (SAS), i.e. supine apnea hypopnea index (AHI) at least twice that of the non-supine AHI
* Patient suffering from severe peripheral neuropathy
* Vulnerable patient in accordance with article L1121-6 of Code de la Santé Publique (CSP)
* Patient already involved in another clinical study that could affect the result of this study
* Pregnant patient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Research Agency, France

OTHER

Sponsor Role collaborator

LivaNova

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Beziers

Béziers, , France

Site Status

University Hospital Grenoble

Grenoble, , France

Site Status

CHU Rennes

Rennes, , France

Site Status

University Hospital Tours

Tours, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IAHO03

Identifier Type: -

Identifier Source: org_study_id