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

LivaNova

Status

Completed

Conditions

Obstructive Sleep Apnea Syndrome

Treatments

Device: Kinesthetic stimulation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02789748

IAHO03

Details and patient eligibility

About

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

Full description

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.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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