Back to results

Early Sleep Apnea Termination Using Sound Stimulation (ESAT)

Primary Purpose

Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Sound stimulation

About this trial

This is an interventional treatment trial for Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Adrien Waeber

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apneas with and without intervention

Arm Description

Each patient will be his own control.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Duration of the apnea (seconds)

Duration of breathing cessation assessed by nasal cannula (in seconds)

Percentage of sound stimulations associated with cortical and subcortical arousals (%)

Each arousal will be assessed using the polysomnography EEG

Percentage of sound stimulations associated with autonomic arousals (%)

Autonomic arousals will be assessed by pulse wave amplitude variations

Magnitude of autonomic reactions (% of pulse wave amplitude drop)

Magnitude (% of baseline) of pulse wave amplitude drop following different types of sound stimulations

Duration of EEG arousals (in seconds)

Duration (in seconds) of EEG arousals following different types of sound stimulations

Magnitude of autonomic reactions (duration of pulse wave amplitude drop)

Duration of pulse wave amplitude drop following different types of sound stimulations (in seconds)

Full Information

NCT ID

NCT03753971

First Posted

November 8, 2018

Last Updated

November 3, 2020

Sponsor

Raphael Heinzer

1. Study Identification

Unique Protocol Identification Number

NCT03753971

Brief Title

Early Sleep Apnea Termination Using Sound Stimulation

Acronym

ESAT

Official Title

Early Sleep Apnea Termination Using Sound Stimulation

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

January 16, 2019 (Actual)

Primary Completion Date

December 1, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Raphael Heinzer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apneas with and without intervention

Arm Type

Experimental

Arm Description

Each patient will be his own control.

Intervention Type

Other

Intervention Name(s)

Sound stimulation

Intervention Description

Short sound stimulations will be emitted through a head band during sleep apneas

Primary Outcome Measure Information:

Title

Differences in sleep apnea associted oxygen desaturations

Description

Differences in the magnitude of blood oxygen desaturation between treated and untreated sleep apnea events (in % of SaO2)

Time Frame

During the polysomnography night

Secondary Outcome Measure Information:

Title

Duration of the apnea (seconds)

Description

Duration of breathing cessation assessed by nasal cannula (in seconds)

Time Frame

During the polysomnography night

Title

Percentage of sound stimulations associated with cortical and subcortical arousals (%)

Description

Each arousal will be assessed using the polysomnography EEG

Time Frame

During the polysomnography night

Title

Percentage of sound stimulations associated with autonomic arousals (%)

Description

Autonomic arousals will be assessed by pulse wave amplitude variations

Time Frame

During the polysomnography night

Title

Magnitude of autonomic reactions (% of pulse wave amplitude drop)

Description

Magnitude (% of baseline) of pulse wave amplitude drop following different types of sound stimulations

Time Frame

During the polysomnography night

Title

Duration of EEG arousals (in seconds)

Description

Duration (in seconds) of EEG arousals following different types of sound stimulations

Time Frame

During the polysomnography night

Title

Magnitude of autonomic reactions (duration of pulse wave amplitude drop)

Description

Duration of pulse wave amplitude drop following different types of sound stimulations (in seconds)

Time Frame

During the polysomnography night

Other Pre-specified Outcome Measures:

Title

Patients' perception of the sounds emitted during sleep (visual analog scale 0-10)

Description

Perception of the sound stimulations (number per night)

Time Frame

Morning after the polysomnography night

Title

Patients' tolerance to the sounds (visual analog scale 0-10)

Description

VAS scale reflecting the annoyance associted with the sounds emitted during their sleep

Time Frame

Morning after the polysomnography

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raphael Heinzer, Pr.

Organizational Affiliation

Centre d'investigation et de recherche sur le sommeil (CHUV)

Official's Role

Study Director

Facility Information:

Facility Name

Adrien Waeber

City

Jouxtens-Mézery

State/Province

Vaud

ZIP/Postal Code

1008

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33383395

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.

Results Reference

derived

Learn more about this trial

Early Sleep Apnea Termination Using Sound Stimulation

We'll reach out to this number within 24 hrs