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

NCT02789748 | Completed

• 1 other identifier: IAHO03
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Adverse device effect

  Day 1 post-discharge

• Effect on apneas/hypopneas duration

  Day 1 post-discharge

• Effect on modified apnea hypopnea index

  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

  Day 1 post-discharge

Study Arms (2)

Treatment ON

EXPERIMENTAL

Kinesthetic stimulation administered during one night

Device: Kinesthetic stimulation

Treatment OFF

NO INTERVENTION

NO kinesthetic stimulation administered during one night

Interventions

Kinesthetic stimulation DEVICE

Activation of mechanoreceptors by vibration bursts

Treatment ON

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LivaNova: lead
• National Research Agency, France: collaborator

Study Sites (4)

Hospital Beziers

Béziers, 34500, France

Location

University Hospital Grenoble

Grenoble, 38043, France

Location

CHU Rennes

Rennes, France

Location

University Hospital Tours

Tours, 37 044, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: June 3, 2016
• Study Start: June 1, 2016
• Primary Completion: October 2, 2017
• Study Completion: October 2, 2017
• Last Updated: October 5, 2017

Record last verified: 2017-10

Locations

FR (4)