Early Sleep Apnea Termination Using Sound Stimulation (ESAT)

Raphael Heinzer

Status: Completed

Conditions: Sleep Apnea

Treatments: Other: Sound stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03753971

19121997

2018-02033 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Apneas with and without intervention

Experimental group

Description:

Each patient will be his own control.

Treatment:

Other: Sound stimulation