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Completed

NCT Number: NCT03753971

Early Sleep Apnea Termination Using Sound Stimulation

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.

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adrien Waeber

Jouxtens-Mézery, Canton of Vaud, 1008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sound stimulation

Other

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

Primary outcomes

  1. Differences in sleep apnea associted oxygen desaturations

    Time frame: During the polysomnography night

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

Secondary outcomes

  1. Duration of the apnea (seconds)

    Time frame: During the polysomnography night

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

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

    Time frame: During the polysomnography night

    Each arousal will be assessed using the polysomnography EEG

  3. Percentage of sound stimulations associated with autonomic arousals (%)

    Time frame: During the polysomnography night

    Autonomic arousals will be assessed by pulse wave amplitude variations

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

    Time frame: During the polysomnography night

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

  5. Duration of EEG arousals (in seconds)

    Time frame: During the polysomnography night

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

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

    Time frame: During the polysomnography night

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

Other outcomes

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

    Time frame: Morning after the polysomnography night

    Perception of the sound stimulations (number per night)

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

    Time frame: Morning after the polysomnography

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

Sponsors and collaborators

Lead sponsor

Raphael Heinzer

Other

Registry information

Acronym: ESAT

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2018
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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