NCT04157972

Brief Summary

This study will investigate the effects on the SIMEOX technology on static hyperinflation in patients with chronic obstructive pulmonary disease (COPD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 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

Study Start

First participant enrolled

August 5, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2021

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

November 6, 2019

Last Update Submit

November 18, 2023

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (3)

  • Change in functional residual capacity (FRC) using body plethysmography

    FRCpleth before, after and 30 minutes after performing SIMEOX and PEP will be compared.

    15 minutes

  • Change in functional residual capacity (FRC) using helium dilution

    FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.

    5 minutes

  • Change in air trapping

    FRCpleth - FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.

    20 minutes

Study Arms (2)

SIMEOX

ACTIVE COMPARATOR

Participants will have to perform 20 minutes of SIMEOX. Passive exhalation is required using the SIMEOX, starting from tidal volume and going until achieving residual volume.

Device: SIMEOX

PEP

ACTIVE COMPARATOR

Participants will have to perform 20 minutes of PEP. Active exhalation is required using a PEP device, starting from tidal volume and going until achieving residual volume.

Device: PEP

Interventions

SIMEOXDEVICE

SIMEOX is a device generating a succession of gentle depression at the mouth.

SIMEOX
PEPDEVICE

A PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration.

PEP

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic obstructive pulmonary disease,
  • Forced expiratory volume in 1s (FEV1) \<80% of predicted value,
  • Stable condition (no pulmonary exacerbation for more than 28 days).

You may not qualify if:

  • Routine use of one of the two treatments - SIMEOX and/or PEP,
  • Inability to understand or carry out the instructions,
  • Severe cardiac comorbidity, neuromuscular disease,
  • Severe scoliosis,
  • Patient with a pacemaker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

Location

Related Publications (3)

  • de Macedo JRFF, Aubriot AS, Reychler G, Penelle M, Gohy S, Poncin W. The intermittent intrapulmonary deflation technique for airway clearance in patients with cystic fibrosis: A randomized trial. Respir Med Res. 2024 Nov;86:101094. doi: 10.1016/j.resmer.2024.101094. Epub 2024 Feb 29.

    PMID: 38843595DERIVED

  • Ribeiro Fonseca Franco de Macedo J, Reychler G, Poncin W, Liistro G. Effects of the intermittent intrapulmonary deflation technique on expiratory flow limitation: an in vitro study. J Clin Monit Comput. 2024 Feb;38(1):69-75. doi: 10.1007/s10877-023-01093-3. Epub 2023 Nov 2.

    PMID: 37917211DERIVED

  • de Macedo JRFF, Reychler G, Liistro G, Poncin W. Short-Term Effect of Intermittent Intrapulmonary Deflation on Air Trapping in Patients With COPD. Respir Care. 2023 Apr;68(4):478-487. doi: 10.4187/respcare.10398. Epub 2023 Feb 21.

    PMID: 36810360DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The visits include sessions (test 1 and 2) with SIMEOX or a positive expiratory pressure device (PEP) (chosen according to the subject's randomization) lasting 20 minutes, each followed by a rest period of 30 minutes. Lung function tests will be performed before, after and 30 minutes after performing the devices (SIMEOX and PEP).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 8, 2019

Study Start

August 5, 2019

Primary Completion

March 16, 2021

Study Completion

March 16, 2021

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)