Early Sleep Apnea Termination Using Sound Stimulation

Sleep Apnea Clinical Trial

— ESAT  

Official title:

Early Sleep Apnea Termination Using Sound Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03753971
• Other study ID #: 19121997
• Secondary ID: 2018-02033
• Status: Completed
• Phase: N/A
• Start date: January 16, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2020
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 31, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Other:
• Sound stimulation
Short sound stimulations will be emitted through a head band during sleep apneas

Locations

Country	Name	City	State
Switzerland	Adrien Waeber	Jouxtens-Mézery	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Raphael Heinzer

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients' perception of the sounds emitted during sleep (visual analog scale 0-10)	Perception of the sound stimulations (number per night)	Morning after the polysomnography night
Other	Patients' tolerance to the sounds (visual analog scale 0-10)	VAS scale reflecting the annoyance associted with the sounds emitted during their sleep	Morning after the polysomnography
Primary	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	Duration of the apnea (seconds)	Duration of breathing cessation assessed by nasal cannula (in seconds)	During the polysomnography night
Secondary	Percentage of sound stimulations associated with cortical and subcortical arousals (%)	Each arousal will be assessed using the polysomnography EEG	During the polysomnography night
Secondary	Percentage of sound stimulations associated with autonomic arousals (%)	Autonomic arousals will be assessed by pulse wave amplitude variations	During the polysomnography night
Secondary	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
Secondary	Duration of EEG arousals (in seconds)	Duration (in seconds) of EEG arousals following different types of sound stimulations	During the polysomnography night
Secondary	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