NCT04793724

Respiratory Physiotherapy Performed by Simeox In Patients With Primary Ciliary Dyskinesia

Completed NA Last updated 2 March 2023

What this trial tests

NA trial testing Simeox in Primary Ciliary Dyskinesia in 30 participants. Completed in 28 February 2023.

Timeline

15 July 2019

Primary endpoint
30 September 2022

28 February 2023

Quick facts

Lead sponsor	University Hospital, Motol
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	supportive care
Enrollment	30
Start date	15 July 2019
Primary completion	30 September 2022
Estimated completion	28 February 2023
Sites	1 location across Czechia

Drugs / interventions tested

• Simeox
• PARI O PEP

Conditions studied

• Primary Ciliary Dyskinesia — all drugs for Primary Ciliary Dyskinesia →

Sponsor

University Hospital, Motol

Who can join

Adults 4 to 18, any sex, with Primary Ciliary Dyskinesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary ciliary dyskinesia (PCD) is characterized by impaired airway clearance and mucus stagnation. This results in recurrent upper and lower respiratory tract infections often leading to chronic inflammation and, if not treated early and properly, to irreversible functional and structural changes of the respiratory tract. As there is no causal treatment of PCD yet, airway clearance techniques (ACT) provide fundamental care for these patients.

Simeox is a new airway clearance device, recently developed by the French company PhysioAssist. This technology is based on pneumatic vibrations generated by the device itself. Vibrations are induced by rapidly alternating between atmospheric and negative pressure as the patient exhales, providing the most effective clearance of mucus from the lungs. Vibrations of different intensity and frequency are known to alter the rheological properties of mucus in the airways, whilst the negative pressure during exhalation helps to mobilise and drain the mucus to the central bronchi.

Although there have not yet been any evidence based papers published clarifying the effect of Simeox specifically in patients with PCD, using up-to-date information, experience, and positive feedback from our patients, we assume that there could be a significant benefit for the effectiveness of ACT.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.