Early Sleep Apnea Termination Using Sound Stimulation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Sleep Apnea Termination Using Sound Stimulation

Conditions
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Sleep Apnea

Intervention / Treatment
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* Other: Sound stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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% Exclusion Criteria: Perception deafness Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc., Professional drivers

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apneas with and without intervention<br>Each patient will be his own control. | Other: Sound stimulation<br>* Short sound stimulations will be emitted through a head band during sleep apneas<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in sleep apnea associted oxygen desaturations | Differences in the magnitude of blood oxygen desaturation between treated and untreated sleep apnea events (in % of SaO2) | During the polysomnography night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the apnea (seconds) | Duration of breathing cessation assessed by nasal cannula (in seconds) | During the polysomnography night | 
| Percentage of sound stimulations associated with cortical and subcortical arousals (%) | Each arousal will be assessed using the polysomnography EEG | During the polysomnography night | 
| Percentage of sound stimulations associated with autonomic arousals (%) | Autonomic arousals will be assessed by pulse wave amplitude variations | During the polysomnography night | 
| Magnitude of autonomic reactions (% of pulse wave amplitude drop) | Magnitude (% of baseline) of pulse wave amplitude drop following different types of sound stimulations | During the polysomnography night | 
| Duration of EEG arousals (in seconds) | Duration (in seconds) of EEG arousals following different types of sound stimulations | During the polysomnography night | 
| Magnitude of autonomic reactions (duration of pulse wave amplitude drop) | Duration of pulse wave amplitude drop following different types of sound stimulations (in seconds) | During the polysomnography night |