Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2019-01-16
2019-12-31
Brief Summary
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Detailed Description
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20 OSA subjects will be recruited and studied with polysomnography and a head band allowing to emit short sound stimulations during sleep. the study will take nplace at the Center for investigation and research in sleep (CIRS)
The magnitude of oxygen desaturations following apnea with and without sound stimulations will be compared. The effects of different types of sound stimulations on the magnitude of cortical and autonomic reactions will also be studied as well as the patients' subjective perception of the sounds.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Apneas with and without intervention
Each patient will be his own control.
Sound stimulation
Short sound stimulations will be emitted through a head band during sleep apneas
Interventions
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Sound stimulation
Short sound stimulations will be emitted through a head band during sleep apneas
Eligibility Criteria
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Inclusion Criteria
* Able to give informed consent as documented by signature
* Apnea / hypopnea index \> 30 / h (severe)
* Obstructive Apnea Index \> 15 / h
* Mean amplitude of desaturations (during diagnostic night) ≥ 5%
Exclusion Criteria
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.,
* Professional drivers
18 Years
ALL
No
Sponsors
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Raphael Heinzer
OTHER
Responsible Party
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Raphael Heinzer
Professor
Principal Investigators
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Raphael Heinzer, Pr.
Role: STUDY_DIRECTOR
Centre d'investigation et de recherche sur le sommeil (CHUV)
Locations
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Adrien Waeber
Jouxtens-Mézery, Canton of Vaud, Switzerland
Countries
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References
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Waeber A, Arnal PJ, Lecciso G, Albir D, Mignot E, Heinzer R. Acoustic stimulation time-locked to the beginning of sleep apnea events reduces oxygen desaturations: a pilot-study. Sleep Med. 2021 Feb;78:38-42. doi: 10.1016/j.sleep.2020.12.006. Epub 2020 Dec 11.
Other Identifiers
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2018-02033
Identifier Type: OTHER
Identifier Source: secondary_id
19121997
Identifier Type: -
Identifier Source: org_study_id