Trials / Completed
CompletedNCT02789748
PErsonalized and Adaptive Kinesthetic stImulation Therapy, Based on Cardio-respiratory Holter moNitoring, for Sleep Apnea syndrOmes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- LivaNova · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Kinesthetic stimulation | Activation of mechanoreceptors by vibration bursts |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2017-10-02
- Completion
- 2017-10-02
- First posted
- 2016-06-03
- Last updated
- 2017-10-05
Locations
4 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02789748. Inclusion in this directory is not an endorsement.