Sleep Apnea
Conditions
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.
Interventions
OTHERSound stimulation
Short sound stimulations will be emitted through a head band during sleep apneas
Sponsors
Raphael Heinzer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of the apnea (seconds) | During the polysomnography night | Duration of breathing cessation assessed by nasal cannula (in seconds) |
| Percentage of sound stimulations associated with cortical and subcortical arousals (%) | During the polysomnography night | Each arousal will be assessed using the polysomnography EEG |
| Percentage of sound stimulations associated with autonomic arousals (%) | During the polysomnography night | Autonomic arousals will be assessed by pulse wave amplitude variations |
| Duration of EEG arousals (in seconds) | During the polysomnography night | Duration (in seconds) of EEG arousals following different types of sound stimulations |
| 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) |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patients' perception of the sounds emitted during sleep (visual analog scale 0-10) | Morning after the polysomnography night | Perception of the sound stimulations (number per night) |
| Patients' tolerance to the sounds (visual analog scale 0-10) | Morning after the polysomnography | VAS scale reflecting the annoyance associted with the sounds emitted during their sleep |
Countries
Switzerland
Outcome results
None listed