Early Sleep Apnea Termination Using Sound Stimulation (ESAT)

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea
• Intervention / Treatment: Other: Sound stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Jouxtens-Mézery, Vaud, Switzerland, 1008
      • Adrien Waeber

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Raphael Heinzer
• Investigators: Study Director: Raphael Heinzer, Pr., Centre d'investigation et de recherche sur le sommeil (CHUV)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2019
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 22, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Apnea
• Other Study ID Numbers: 19121997; 2018-02033 (Other Identifier: Swissethics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No