Clinical trial NCT03753971: Early Sleep Apnea Termination Using Sound Stimulation
Official title: Early Sleep Apnea Termination Using Sound Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in sleep apnea associted oxygen desaturations
timeFrame: During the polysomnography night
Secondary outcomes:
measure: Duration of the apnea (seconds)
timeFrame: During the polysomnography night
measure: Percentage of sound stimulations associated with cortical and subcortical arousals (%)
timeFrame: During the polysomnography night
measure: Percentage of sound stimulations associated with autonomic arousals (%)
timeFrame: During the polysomnography night
measure: Magnitude of autonomic reactions (% of pulse wave amplitude drop)
timeFrame: During the polysomnography night
measure: Duration of EEG arousals (in seconds)
timeFrame: During the polysomnography night
measure: Magnitude of autonomic reactions (duration of pulse wave amplitude drop)
timeFrame: During the polysomnography night
Other outcomes:
measure: Patients' perception of the sounds emitted during sleep (visual analog scale 0-10)
timeFrame: Morning after the polysomnography night
measure: Patients' tolerance to the sounds (visual analog scale 0-10)
timeFrame: Morning after the polysomnography
Locations:
city: Jouxtens-Mézery
country: Switzerland
facility: Adrien Waeber
state: Vaud
Study officials:
affiliation: Centre d'investigation et de recherche sur le sommeil (CHUV)
name: Raphael Heinzer, Pr.
role: STUDY_DIRECTOR
References:
citation: 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.