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

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Device: Kinesthetic stimulation

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Beziers, France, 34500
    • Hospital Beziers
  • Grenoble, France, 38043
    • University Hospital Grenoble
  • Rennes, France
    • Chu Rennes
  • Tours, France, 37 044
    • university hospital Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment ON; Kinesthetic stimulation administered during one night	Device: Kinesthetic stimulation; Activation of mechanoreceptors by vibration bursts
No Intervention: Treatment OFF; NO kinesthetic stimulation administered during one night

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of responder to the therapy	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	Day 1 post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse device effect	Adverse Events related to the investigational device	Day 1 post-discharge
Effect on apneas/hypopneas duration	Therapy effect on shortening respiratory events	Day 1 post-discharge
Effect on modified apnea hypopnea index	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	Day 1 post-discharge
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	The micro-arousal index will be calculated on the polysomnography recording.	Day 1 post-discharge
Effect on an objective measure of somnolence (Osler)	Osler test (optional) performed after treated night and non-treated night	Day 1 post-discharge

Collaborators and Investigators

• Sponsor: LivaNova
• Collaborators: National Research Agency, France

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): October 2, 2017
• Study Completion (Actual): October 2, 2017

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: May 30, 2016
• First Posted (Estimate): June 3, 2016

Study Record Updates

• Last Update Posted (Actual): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
• Other Study ID Numbers: IAHO03