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

Obstructive Sleep Apnea Syndrome Clinical Trial

— EKINOx  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02789748
• Other study ID #: IAHO03
• Status: Completed
• Phase: N/A
• First received: February 18, 2016
• Last updated: October 3, 2017
• Start date: June 1, 2016
• Est. completion date: October 2, 2017

Study information

• Verified date: October 2017
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2, 2017
• Est. primary completion date: October 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Device:
• Kinesthetic stimulation
Activation of mechanoreceptors by vibration bursts

Locations

Country	Name	City	State
France	Hospital Beziers	Beziers
France	University Hospital Grenoble	Grenoble
France	CHU Rennes	Rennes
France	University Hospital Tours	Tours

Sponsors (2)

Lead Sponsor	Collaborator
LivaNova	National Research Agency, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse device effect	Adverse Events related to the investigational device	Day 1 post-discharge
Secondary	Effect on apneas/hypopneas duration	Therapy effect on shortening respiratory events	Day 1 post-discharge
Secondary	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
Secondary	Instantaneous heart rate measurement (bpm) during the night ON and the night OFF		Day 1 post-discharge
Secondary	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
Secondary	Effect on an objective measure of somnolence (Osler)	Osler test (optional) performed after treated night and non-treated night	Day 1 post-discharge