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Benefit of High-flow Nasal Cannula on Persistent Dyspnea in Ild

ConditionILD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

The main purpose of this study is to evaluate the effects of high-flow nasal therapy (HFNT) oxygen compared to long-term oxygen therapy (LTOT) on dyspnea and quality of life in intersititial lung disease patients with chronic respiratory failure and persistent breathlessness in whom LTOT has already been initiated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Intertitial lung disease

Persistant dyspnea (mMRC≥3)

Long-term oxygen therapy at least for 3 months

Disqualifiers

Chronic respiratory disease (COPD, lung cancer)

Pneumothorax,

Pneumomediastinum,

Active smoker,

Trial design

Design model

Crossover

Treatments tested in this trial

  • long-term oxygen therapy (LTOT)

    Procedure/Surgery

    Usual care with LTOT for 2 weeks

  • High Flow Nasal Therapy (HFNT)

    Procedure/Surgery

    High Flow Nasal delivered by myAirvo3 (4 hours minimum and during th 3-minute chair rise test, 30L/min, 34°C, identical O2 flow rate as LTOT) for 2 weeks

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Long-Term Oxygen therapy (LTOT) then High Flow Nasal Therapy (HFNT)Other 2 interventions
Group B: High Flow Nasal Therapy (HFNT) then Long-Term Oxygen therapy (LTOT)Other 2 interventions

Trial outcomes

Primary outcomes

1

SGRQ questionnaire : Saint George's Respiratory Questionnaire (symptom component)

Symptom component of SGRQ : Scores range from 0 to 100, with higher scores indicating more limitations.

Time frame
2 weeks

Secondary outcomes

1

Dyspnea assessement : dyspnoea-12

Dyspnea-12 score range from 0 to 36, with higher score indicating worse breathlessness

Time frame
2 weeks
2

Dyspnea assessement : mMRC: Modified Medical Research Council

mMRC score : range frome 0 (low) to 4(high) and assesses the intensity of dyspnea

Time frame
2 weeks
3

Dyspnea assessement : MDP: Multidimensional dyspnea profile

* Immediate affective score range from 0 to 10 with higher score indicating worse breathlessness * Sensory score range from 0 to 50 with higher score indicating worse breathlessness * Emotional score range from 0 to 50 with higher score indicating worse breathlessness

Time frame
2 weeks
4

Quality of life (SGRQ questionnaire) : S.George's Respiratory Questionnaire

* Total score range from 0 to 100 with higher score indicating more limitations * Activity subscore range from 0 to 100 with higher score indicating more limitations * Impact sub-score range from 0 to 100 with higher score indicating more limitations

Time frame
2 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: