Early Sleep Apnea Termination Using Sound Stimulation
- Conditions
- Sleep Apnea
- Interventions
- Other: Sound stimulation
- Registration Number
- NCT03753971
- Lead Sponsor
- Raphael Heinzer
- Brief Summary
Current evidence suggest that sleep apnea-associated oxygen desaturations may induce cardiovascular morbidities in the long term, whereas arousals associated with sleep apneas seem to induce mainly transient nocturnal hypertension. Reducing the occurrence and the magnitude of sleep apnea-associated oxygen desaturations could therefore have a beneficial effect on sleep apnea-associated comobidities. Since sleep apneas usually end with an arousal allowing pharyngeal muscles reactivation, a treatment option could consist of generating an early short awakening to anticipate apnea termination and decrease the risk of oxygen desaturation. The aim of this study is thus to determine if an early sleep apnea termination through the emission of a sound can achieve lower oxygen desaturations compared with "untreated" sleep apneas.
- Detailed Description
The aim of the study is to determine the effect of short sound stimulations on sleep apnea associated desaturations
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- Age > 18 years
- 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%
- Perception deafness
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.,
- Professional drivers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Apneas with and without intervention Sound stimulation Each patient will be his own control.
- Primary Outcome Measures
Name Time Method Differences in sleep apnea associted oxygen desaturations During the polysomnography night Differences in the magnitude of blood oxygen desaturation between treated and untreated sleep apnea events (in % of SaO2)
- Secondary Outcome Measures
Name Time Method Percentage of sound stimulations associated with autonomic arousals (%) During the polysomnography night Autonomic arousals will be assessed by pulse wave amplitude variations
Duration of the apnea (seconds) During the polysomnography night Duration of breathing cessation assessed by nasal cannula (in seconds)
Magnitude of autonomic reactions (% of pulse wave amplitude drop) During the polysomnography night Magnitude (% of baseline) of pulse wave amplitude drop following different types of sound stimulations
Percentage of sound stimulations associated with cortical and subcortical arousals (%) During the polysomnography night Each arousal will be assessed using the polysomnography EEG
Magnitude of autonomic reactions (duration of pulse wave amplitude drop) During the polysomnography night Duration of pulse wave amplitude drop following different types of sound stimulations (in seconds)
Duration of EEG arousals (in seconds) During the polysomnography night Duration (in seconds) of EEG arousals following different types of sound stimulations
Trial Locations
- Locations (1)
Adrien Waeber
🇨🇭Jouxtens-Mézery, Vaud, Switzerland