NCT03428516

Brief Summary

The present study aims to compare muscle sympathetic neural activity by microneurography after one month treatment of fixed versus auto-adjusting CPAP treatment and its impact on arterial blood pressure

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

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

January 17, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

May 16, 2024

Status Verified

July 1, 2022

Enrollment Period

4.7 years

First QC Date

January 17, 2018

Last Update Submit

May 13, 2024

Conditions

Sleep Apnea Syndromes

Outcome Measures

Primary Outcomes (1)

  • Sympathetic tone (MSNA)

    Change from Baseline Sympathetic tone at 1 months

    Change from baseline after one month of intervention

Secondary Outcomes (11)

  • 24 hours Systolic Blood pressure (AMBP)

    Change from baseline after one month of intervention

  • Systolic Blood pressure (office)

    Change from baseline after one month of intervention

  • Diastolic Blood pressure (office) change after 1 month

    Change from baseline after one month of intervention

  • Mean Blood pressure (office)

    Change from baseline after one month of intervention

  • Catecholamines (epinephrine)

    Change from baseline after one month of intervention

  • +6 more secondary outcomes

Study Arms (2)

Fixed CPAP

EXPERIMENTAL

CPAP always deliver air with the same pressure

Device: Fixed CPAP

Auto-adjusting CPAP

ACTIVE COMPARATOR

Auto-CPAP changes the pressure delivered depending on events detected at any time (apnea, hypopnea …) and applies the lowest pressure required to eliminate events.

Device: Auto-adjusting CPAP

Interventions

Fixed CPAPDEVICE

CPAP is a device that applies continous fixed positive pressure to the airways in order to keep them opened during sleep

Fixed CPAP
Auto-adjusting CPAPDEVICE

Auto-adjusting CPAP is a device that applies auto-adjusting continous positive pressure to the airways in order to keep them opened during sleep

Auto-adjusting CPAP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient with OSA (AHI ≥20 / h)
  • patient with daytime sleepiness
  • naive of any pressure treatment of OSA
  • patient able to provide written informed consent
  • not a vulnerable person or legally protected adult.

You may not qualify if:

  • pregnancy
  • Person deprived of liberty or subject to a legal protection measure.
  • Patient with serious heart failure (According to investigator judgment)
  • patient with central sleep apnea index above 20% of AHI
  • Patient with a significant intercurrent pathology that can influence the results. (According to investigator judgment).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38000, France

Location

Related Publications (2)

  • Pepin JL, Tamisier R, Baguet JP, Lepaulle B, Arbib F, Arnol N, Timsit JF, Levy P. Fixed-pressure CPAP versus auto-adjusting CPAP: comparison of efficacy on blood pressure in obstructive sleep apnoea, a randomised clinical trial. Thorax. 2016 Aug;71(8):726-33. doi: 10.1136/thoraxjnl-2015-207700. Epub 2016 Apr 18.

    PMID: 27091542BACKGROUND

  • Treptow E, Pepin JL, Bailly S, Levy P, Bosc C, Destors M, Woehrle H, Tamisier R. Reduction in sympathetic tone in patients with obstructive sleep apnoea: is fixed CPAP more effective than APAP? A randomised, parallel trial protocol. BMJ Open. 2019 Apr 4;9(4):e024253. doi: 10.1136/bmjopen-2018-024253.

    PMID: 30948567DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Renaud Tamisier, MD, PhD

    University Grenoble Alps

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2018

First Posted

February 9, 2018

Study Start

March 1, 2018

Primary Completion

November 17, 2022

Study Completion

November 30, 2022

Last Updated

May 16, 2024

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)