Clinical trial NCT02789748: PErsonalized and Adaptive Kinesthetic stImulation Therapy, Based on Cardio-respiratory Holter moNitoring, for Sleep Apnea syndrOmes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
Collaborators: name: National Research Agency, France
First posted: 2016-06-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Rate of responder to the therapy
timeFrame: Day 1 post-discharge
Secondary outcomes:
measure: Adverse device effect
timeFrame: Day 1 post-discharge
measure: Effect on apneas/hypopneas duration
timeFrame: Day 1 post-discharge
measure: Effect on modified apnea hypopnea index
timeFrame: Day 1 post-discharge
measure: Instantaneous heart rate measurement (bpm) during the night ON and the night OFF
timeFrame: Day 1 post-discharge
measure: Number of arousals per night - comparison night ON and night OFF
timeFrame: Day 1 post-discharge
measure: Effect on an objective measure of somnolence (Osler)
timeFrame: Day 1 post-discharge
Other outcomes:
Locations:
city: Beziers
country: France
facility: Hospital Beziers
city: Grenoble
country: France
facility: University Hospital Grenoble
city: Rennes
country: France
facility: CHU Rennes
city: Tours
country: France
facility: University Hospital Tours
Study officials:
References: