Kinesthetic stimulation
DeviceActivation of mechanoreceptors by vibration bursts
NCT Number: NCT02789748
This study aims at quantifying the performance of kinesthetic stimulation to reduce the burden of obstructive sleep apneas and hypopneas.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hospital Beziers, Béziers, France
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.
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:
Exclusion criteria
Patients who meet any one of these criteria will be excluded from the study:
Activation of mechanoreceptors by vibration bursts
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:
Time frame: Day 1 post-discharge
Adverse Events related to the investigational device
Time frame: Day 1 post-discharge
Therapy effect on shortening respiratory events
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
Time frame: Day 1 post-discharge
Time frame: Day 1 post-discharge
The micro-arousal index will be calculated on the polysomnography recording.
Time frame: Day 1 post-discharge
Osler test (optional) performed after treated night and non-treated night
LivaNova
Industry
Acronym: EKINOx
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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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