Sleep ApneaESATNCT03753971
Early Sleep Apnea Termination Using Sound Stimulation
A study testing Sound stimulation in people with Sleep Apnea, run by Raphael Heinzer at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Sound stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Jan 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- Perception deafness
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.,
- Professional drivers
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sleep Apnea
- Being tested
- Sound stimulation
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound stimulationOther
Short sound stimulations will be emitted through a head band during sleep apneas
| Study group | Role | What they receive |
|---|---|---|
| Apneas with and without intervention | Experimental | Each patient will be his own control. Receives: Other: Sound stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During the polysomnography night
Secondary outcomes (6)
Duration of the apnea (seconds)
Duration of breathing cessation assessed by nasal cannula (in seconds)
Measured: During the polysomnography night
Percentage of sound stimulations associated with cortical and subcortical arousals (%)
Each arousal will be assessed using the polysomnography EEG
Measured: During the polysomnography night
Percentage of sound stimulations associated with autonomic arousals (%)
Autonomic arousals will be assessed by pulse wave amplitude variations
Measured: 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
Measured: During the polysomnography night
Duration of EEG arousals (in seconds)
Duration (in seconds) of EEG arousals following different types of sound stimulations
Measured: 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)
Measured: During the polysomnography night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start16 Jan 2019
- Primary completion1 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raphael Heinzer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raphael Heinzer, University of Lausanne Hospitals
- Investigators
- Raphael Heinzer, Pr., Study director, Centre d'investigation et de recherche sur le sommeil (CHUV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753971
- Sponsor's protocol ID
- 19121997
- Other IDs
- 2018-02033, 2018
- Acronym
- ESAT
- Status last verified
- Nov 2020
- First submitted
- 8 Nov 2018
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33383395
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Sleep Apnea Termination Using Sound Stimulation
- ClinicalTrials.gov ID
- NCT03753971
- Acronym / sponsor ID
- ESAT / 19121997
- Conditions
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Raphael HeinzerUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apneas with and without intervention | Experimental | Other: Sound stimulationEach patient will be his own control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (3 listed)
- Perception deafness
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.,
- Professional drivers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sound stimulationShort sound stimulations will be emitted through a head band during sleep apneas | Other | Apneas with and without intervention |
Primary outcome
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)
6 secondary outcomes
Duration of the apnea (seconds)
Time frame: During the polysomnography night
Percentage of sound stimulations associated with cortical and subcortical arousals (%)
Time frame: During the polysomnography night
Percentage of sound stimulations associated with autonomic arousals (%)
Time frame: During the polysomnography night
Magnitude of autonomic reactions (% of pulse wave amplitude drop)
Time frame: During the polysomnography night
Duration of EEG arousals (in seconds)
Time frame: During the polysomnography night
Magnitude of autonomic reactions (duration of pulse wave amplitude drop)
Time frame: During the polysomnography night
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Derived from this study: PubMed 33383395Waeber 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael Heinzer, Pr. study director
Centre d'investigation et de recherche sur le sommeil (CHUV)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sound stimulation in people with Sleep Apnea, run by Raphael Heinzer at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in sleep apnea associted oxygen desaturations (time frame: During the polysomnography night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03753971, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.