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

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ClinicalTrials.gov Identifier: NCT02789748
Recruitment Status : Completed
First Posted : June 3, 2016
Last Update Posted : October 5, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study aims at quantifying the performance of kinesthetic stimulation to reduce the burden of obstructive sleep apneas and hypopneas.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Syndrome 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Actual Study Start Date : June 1, 2016
Primary Completion Date : October 2, 2017
Study Completion Date : October 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789748


Locations
France
Hospital Beziers
Beziers, France, 34500
University Hospital Grenoble
Grenoble, France, 38043
CHU Rennes
Rennes, France
University Hospital Tours
Tours, France, 37 044
Sponsors and Collaborators
LivaNova
National Research Agency, France
More Information

Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT02789748     History of Changes
Other Study ID Numbers: IAHO03
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Syndrome
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases