Evaluation of the Quality of Life of Patients With DBB Wi... | NCT06820983

Studies
Evaluation of the Quality of Life of Patients With DBB With the Installation of OPEP

NCT06820983

Sponsor

Centre Hospitalier Universitaire, Amiens

Status

Recruiting

Last Update Posted

Jan 23, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Bronchiectasis
Quality of Life
Physiotherapy

Interventions

adult questionnary for parents of children aged 8 to 13
Quality of life questionnaire for children aged 8 to 13
Quality of life questionnaire for adolescents aged 14 to 17
Quality of life questionnaire for adults
A satisfaction adherence questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2024Actual

Primary Completion Date

Apr 2026Estimated

Completion Date

Apr 2026Estimated

First Submitted Date

Feb 6, 2025

First Submission Date that Met QC Criteria

Feb 6, 2025

First Posted Date

Feb 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2026

Last Update Posted Date

Jan 23, 2026Actual

Name	Class
Hôpital Armand Trousseau	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To carry out an assessment of compliance and quality of life in a population (children and adults) with DDB before and after the use of an oscillating PEP. The aim is to determine the impact of the use of oscillating PEP on the daily life of this population in particular.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
adult questionnary for parents of children aged 8 to 13	Other	Quality of life questionnaire for parents of children aged 8 to 13
Quality of life questionnaire for children aged 8 to 13	Other	Quality of life questionnaire for children aged 8 to 13
Quality of life questionnaire for adolescents aged 14 to 17	Other	Quality of life questionnaire for adolescents aged 14 to 17
Quality of life questionnaire for adults	Other	Quality of life questionnaire for adults
A satisfaction adherence questionnaire	Other	A satisfaction adherence questionnaire will also be distributed to patients after several months' use of oscillating PEP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Variation of patient quality of life before and after OPEP installation	quality of life is determined by qustionnaire	18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children (from 8 years of age) and adults over 18 years of age with DDB who doesn't use oscillating PEP.

The study population will be clinically stable and will be seen in follow-up consultations.

Exclusion Criteria:

Children under 8 years of age.
Patients who use an OPEP
Patients in the acute exacerbation phase of their DDB
Patients who are not under regular consultation
Patients with severe, uncontrolled co-morbidities
Patients with cognitive or psychiatric disorders preventing proper adherence to the study protocol
Patients taking part simultaneously in another clinical study that could interfere with the results of the OPEP study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas PINTO, MD	Contact	33+3 22 08 80 00		pinto.thomas@chu-amiens.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Amiens-Picardie	Recruiting	Amiens		80054	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases