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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Device: Kinesthetic stimulation

• Registration Number: NCT02789748
• Lead Sponsor: LivaNova

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-05-30
• Study Start: 2016-06-01
• Study First Posted: 2016-06-03
• Status Verified: 2017-10
• Primary Completion: 2017-10-02
• Study Completion: 2017-10-02
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment ON	Kinesthetic stimulation	Kinesthetic stimulation administered during one night

Primary Outcome Measures

Name	Time	Method
Rate of responder to the therapy	Day 1 post-discharge	A patient is defined as 'responder' to the therapy by comparison of the treated night to the non-treated night based on: * The oxygen desaturation index (ODI); * The time spent below 90% of oxygen saturation or; * The apnea hypopnea index (AHI) reduction

Secondary Outcome Measures

Name	Time	Method
Adverse device effect	Day 1 post-discharge	Adverse Events related to the investigational device
Effect on apneas/hypopneas duration	Day 1 post-discharge	Therapy effect on shortening respiratory events
Effect on modified apnea hypopnea index	Day 1 post-discharge	The modified apnea hypopnea indices (AHIs) will be compared between the treated and non-treated night and defined based on the duration of the respiratory disorders
Instantaneous heart rate measurement (bpm) during the night ON and the night OFF	Day 1 post-discharge
Number of arousals per night - comparison night ON and night OFF	Day 1 post-discharge	The micro-arousal index will be calculated on the polysomnography recording.
Effect on an objective measure of somnolence (Osler)	Day 1 post-discharge	Osler test (optional) performed after treated night and non-treated night

Trial Locations

Locations (4)

Hospital Beziers; 🇫🇷 Beziers, France

CHU Rennes; 🇫🇷 Rennes, France

University Hospital Tours; 🇫🇷 Tours, France

University Hospital Grenoble; 🇫🇷 Grenoble, France