NCT03753971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 16, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

November 8, 2018

Last Update Submit

November 3, 2020

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Duration of the apnea (seconds)

    During the polysomnography night

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

    During the polysomnography night

  • Percentage of sound stimulations associated with autonomic arousals (%)

    During the polysomnography night

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

    During the polysomnography night

  • Duration of EEG arousals (in seconds)

    During the polysomnography night

  • +1 more secondary outcomes

Other Outcomes (2)

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

    Morning after the polysomnography night

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

    Morning after the polysomnography

Study Arms (1)

Apneas with and without intervention

EXPERIMENTAL

Each patient will be his own control.

Other: Sound stimulation

Interventions

Sound stimulationOTHER

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

Apneas with and without intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • Perception deafness
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.,
  • Professional drivers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adrien Waeber

Jouxtens-Mézery, Canton of Vaud, 1008, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 33383395DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Raphael Heinzer, Pr.

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 27, 2018

Study Start

January 16, 2019

Primary Completion

December 1, 2019

Study Completion

December 31, 2019

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)