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Completed

NCT Number: NCT02789748

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Beziers, Béziers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kinesthetic stimulation

Device

Activation of mechanoreceptors by vibration bursts

Primary outcomes

  1. Rate of responder to the therapy

    Time frame: 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 outcomes

  1. Adverse device effect

    Time frame: Day 1 post-discharge

    Adverse Events related to the investigational device

  2. Effect on apneas/hypopneas duration

    Time frame: Day 1 post-discharge

    Therapy effect on shortening respiratory events

  3. Effect on modified apnea hypopnea index

    Time frame: 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

  4. Instantaneous heart rate measurement (bpm) during the night ON and the night OFF

    Time frame: Day 1 post-discharge

  5. Number of arousals per night - comparison night ON and night OFF

    Time frame: Day 1 post-discharge

    The micro-arousal index will be calculated on the polysomnography recording.

  6. Effect on an objective measure of somnolence (Osler)

    Time frame: Day 1 post-discharge

    Osler test (optional) performed after treated night and non-treated night

Sponsors and collaborators

Lead sponsor

LivaNova

Industry

Collaborators

  • National Research Agency, France

Registry information

Acronym: EKINOx

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 3, 2016
Registry last updated
Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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