ILDHIGHOXFILDNCT06617078
Benefit of High-flow Nasal Cannula on Persistent Dyspnea in Ild
A study testing long-term oxygen therapy (LTOT) and High Flow Nasal Therapy (HFNT) in people with ILD, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ILD
- What is being tested?
- long-term oxygen therapy (LTOT) and High Flow Nasal Therapy (HFNT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2024to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intertitial lung disease
- Persistant dyspnea (mMRC≥3)
- Long-term oxygen therapy at least for 3 months
Who cannot join
- Chronic respiratory disease (COPD, lung cancer)
- Pneumothorax,
- Pneumomediastinum,
- Active smoker,
- Patient on non-invasive ventilation or continuous positive airway pressure (CPAP),
- Pregnancy or breastfeeding,
Show all 10Show fewer
- Unable to read or understand questionnaires,
- No written consent,
- Patients under guardianship,
- No health assurance coverage
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Benefit of High-flow Nasal Cannula on Persistent Dyspnea in Interstitial Lung Disease: Randomized Multicentric Cross-over 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.
Read the detailed description
The study will be a non-blinded, two-arm, crossover (2 periods of 2 weeks each), randomised controlled superiority multicentre trial comparing the effect of HFNT on persistent dyspnoea in intersititial lung disease patients with chronic respiratory failure as compared to LTOT over a two-week period. The oxygen flow rate with HFNT will be the same as for usual care. The HFNT will be used during the night and during the 3-minute chair rise test, it can be used during the day depending on the patient's needs. During the rest of the time, the LTOT will be used as in usual care. Participants will be randomised to receive (1) 2 weeks of LTOT then 2 weeks of LTOT+HFNT or (2) 2 weeks of LTOT+HFNT then 2 weeks of LTOT. The investigators will determine the effect of HFNT on quality of life and dyspnoea. The investigators will also study the effect of HFNT on secondary outcomes listed below. Each assessment will be performed at the end of each 2-week period. Polysomnography will be optional. The study will be conducted in 42 patients with LTOT suffering from persistent breathlessness.
With a total sample of 38 patients and a crossover design, if the real difference on the Saint George's Respiratory Questionnaire (SGRQ) is 6, the standard deviation of the matched difference is 12.5 and the significance threshold is 5%, a two-tailed Student's t test will have a power of 80% to conclude that the difference is significantly different from 0 (Calculated using PASS 14.0.14, Analysis of a cross-over design using difference).These hypotheses are based on the values observed in the article by Nagata et al. (PMID: 29283682), in patients with Chronic Obstructive Pulmonary Diseaes of the same severity, which reported an improvement in the SGRQ-s of -10.8 (95% CI: -15.3; -6.3, i.e. SD of 12.4) with HFNT administered at night for 6 weeks versus LTOT Another study (PMID: 31308647) reported an improvement of -11.9 (CI95% -17.2; -6.6) after an introduction of HFNT. As the minicmal clinical improvement difference for SGRQ is 4, a difference of 6 is considered was both realistic and clinically relevant. A Student's t test allows a conservative approach compared to the use of a linear mixed-effects model retained for the analysis of the primary endpoint.
To take account of reduced precision due to possible loss of follow-up or study withdrawals, the sample was increased by 10%, i.e. 42 patients: 21 in the HFNT+LTOT then LTOT sequence and 21 in the LTOT then HFNT+LTOT sequence.
- Conditions
- ILD
- Being tested
- long-term oxygen therapy (LTOT), High Flow Nasal Therapy (HFNT)
- Keywords
- Chronic breathlessness, ILD, high nasal flow canula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
long-term oxygen therapy (LTOT)Procedure or surgery
Usual care with LTOT for 2 weeks
High Flow Nasal Therapy (HFNT)Procedure or 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
| Study group | Role | What they receive |
|---|---|---|
| Long-Term Oxygen therapy (LTOT) then High Flow Nasal Therapy (HFNT) | Other | 2 weeks of LTOT then 2 weeks of LTOT+HFNT Receives: Procedure: long-term oxygen therapy (LTOT); Procedure: High Flow Nasal Therapy (HFNT) |
| High Flow Nasal Therapy (HFNT) then Long-Term Oxygen therapy (LTOT) | Other | 2 weeks of LTOT+HFNT then 2 weeks of LTOT Receives: Procedure: long-term oxygen therapy (LTOT); Procedure: High Flow Nasal Therapy (HFNT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (28)
Dyspnea assessement : dyspnoea-12
Dyspnea-12 score range from 0 to 36, with higher score indicating worse breathlessness
Measured: 2 weeks
Dyspnea assessement : mMRC: Modified Medical Research Council
mMRC score : range frome 0 (low) to 4(high) and assesses the intensity of dyspnea
Measured: 2 weeks
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
Measured: 2 weeks
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
Measured: 2 weeks
Quality of life (K-Bild) : The King's Brief Interstitial Lung Disease (KBILD) questionnaire
Total score range from 0 to 100 with lower score indicating more limitations
Measured: 2 weeks
Quality of life questionnaire (SF12): Short Form 12
Total score range from 0 to 100 with higher score indicating more limitations
Measured: 2 weeks
Anxiety-depression (HADS) : Hospital Anxiety and Depression scale
- Anxiety sub-score range from 0 to 21 with higher score indicating more severe anxiety
- Depression sub-scorerange from 0 to 21 with higher score indicating more severe depression
Measured: 2 weeks
Distance at 6-minutes walk test
Length in meters
Measured: 2 weeks
Dyspnea (Borg score) at the 6-minutes walk test
Score range from 0 to 10 with higher score indicating worst breathlessness
Measured: 2 weeks
Number of rise at the 3-minutes rise chair test
Number of rise
Measured: 2 weeks
Dyspnea (Borg score) at the 3-minutes rise chair test
Score range from 0 to 10 with higher score indicating worst breathlessness
Measured: 2 weeks
Nocturnal capnography
Mean PtcCO2
Measured: 2 weeks
Respiratory rate
- Mean day-time respiratory rate measured by a wearable tele-monitoring device (breaths/min)
- Mean night-time respiratory rate measured by a wearable tele-monitoring device (breaths/min)
Measured: Over 2 weeks
Heart rate
- Mean day-time heart rate measured by a wearable tele-monitoring device (beats/min)
- Mean night-time heart rate measured by a wearable tele-monitoring device (beats/min)
Measured: Over 2 weeks
SpO2
- Mean day-time SpO2 measured by a wearable tele-monitoring device (%)
- Mean night-time SpO2 measured by a wearable tele-monitoring device (%)
Measured: Over 2 weeks
Rest
Mean daily rest hours measured by a wearable tele-monitoring device (hours/day)
Measured: Over 2 weeks
Activity
Mean daily walking hours measured by a wearable tele-monitoring device (hours/day)
Measured: Over 2 weeks
Activity
Mean daily steps measured by a wearable tele-monitoring device (steps/day)
Measured: Over 2 weeks
Sleep Quality only in patients for whom nocturnal polysomnography is performed during one night (optional)
Sleep duration (minutes)
Measured: 2 weeks
Sleep Quality only in patients for whom nocturnal polysomnography is performed during one night (optional)
Onset latency (minutes)
Measured: 2 weeks
Sleep Quality only in patients for whom nocturnal polysomnography is performed during one night (optional)
Percentage of REM sleep (%)
Measured: 2 weeks
Sleep Quality only in patients for whom nocturnal polysomnography is performed during one night (optional)
Sleep efficiency (%)
Measured: 2 weeks
Sleep Quality only in patients for whom nocturnal polysomnography is performed during one night (optional)
Apnoea-hypopnoea index (per hour)
Measured: 2 weeks
Sleep Quality only in patients for whom nocturnal polysomnography is performed during one night (optional)
Index of arousal and micro-arousals (per hour)
Measured: 2 weeks
Sleep Quality only in patients for whom nocturnal polysomnography is performed during one night (optional)
Time spent at SpO2 below 90% (TST90) (%)
Measured: 2 weeks
Acute exacerbation and/or increase in resting oxygen flow
Number of patients with (i) an acute exacerbation defined as the onset or acute worsening of dyspnoea, associated with an increase in radiological lesions (new ground-glass opacities and/or bilateral condensations) not explained by heart failure or overload, or (ii) an increase in resting oxygen flow of more than 2 L/min (on medical prescription).
Measured: 2 weeks
HFNT(High Flow Nasal Therapy) compliance
- Average daily hours of use of the HFNT device
- Average daily hours of use of LTOT
Measured: 2 weeks
HFNT (High Flow Nasal Therapy) acceptability
Side effects
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start15 Oct 2024 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ILDStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Capucine Morélot-Panzini, MD,PhD, Prof, Principal investigator, APHP • Assistance Publique des hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617078
- Sponsor's protocol ID
- APHP210079
- Other IDs
- IDRCB
- Acronym
- HIGHOXFILD
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatiqueet des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of High-flow Nasal Cannula on Persistent Dyspnea in Interstitial Lung Disease: Randomized Multicentric Cross-over Trial
- ClinicalTrials.gov ID
- NCT06617078
- Acronym / sponsor ID
- HIGHOXFILD / APHP210079
- Conditions
- ILD
- Keywords
- Chronic breathlessness, ILD, high nasal flow canula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be a non-blinded, two-arm, crossover (2 periods of 2 weeks each), randomised controlled superiority multicentre trial comparing the effect of HFNT on persistent dyspnoea in intersititial lung disease patients with chronic respiratory failure as compared to LTOT over a two-week period. The oxygen flow rate with HFNT will be the same as for usual care. The HFNT will be used during the night and during the 3-minute chair rise test, it can be used during the day depending on the patient's needs. During the rest of the time, the LTOT will be used as in usual care. Participants will be randomised to receive (1) 2 weeks of LTOT then 2 weeks of LTOT+HFNT or (2) 2 weeks of LTOT+HFNT then 2 weeks of LTOT. The investigators will determine the effect of HFNT on quality of life and dyspnoea. The investigators will also study the effect of HFNT on secondary outcomes listed below. Each assessment will be performed at the end of each 2-week period. Polysomnography will be optional. The study will be conducted in 42 patients with LTOT suffering from persistent breathlessness.
With a total sample of 38 patients and a crossover design, if the real difference on the Saint George's Respiratory Questionnaire (SGRQ) is 6, the standard deviation of the matched difference is 12.5 and the significance threshold is 5%, a two-tailed Student's t test will have a power of 80% to conclude that the difference is significantly different from 0 (Calculated using PASS 14.0.14, Analysis of a cross-over design using difference).These hypotheses are based on the values observed in the article by Nagata et al. (PMID: 29283682), in patients with Chronic Obstructive Pulmonary Diseaes of the same severity, which reported an improvement in the SGRQ-s of -10.8 (95% CI: -15.3; -6.3, i.e. SD of 12.4) with HFNT administered at night for 6 weeks versus LTOT Another study (PMID: 31308647) reported an improvement of -11.9 (CI95% -17.2; -6.6) after an introduction of HFNT. As the minicmal clinical improvement difference for SGRQ is 4, a difference of 6 is considered was both realistic and clinically relevant. A Student's t test allows a conservative approach compared to the use of a linear mixed-effects model retained for the analysis of the primary endpoint.
To take account of reduced precision due to possible loss of follow-up or study withdrawals, the sample was increased by 10%, i.e. 42 patients: 21 in the HFNT+LTOT then LTOT sequence and 21 in the LTOT then HFNT+LTOT sequence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-Term Oxygen therapy (LTOT) then High Flow Nasal Therapy (HFNT) | Other | Procedure: long-term oxygen therapy (LTOT), Procedure: High Flow Nasal Therapy (HFNT)2 weeks of LTOT then 2 weeks of LTOT+HFNT |
| High Flow Nasal Therapy (HFNT) then Long-Term Oxygen therapy (LTOT) | Other | Procedure: long-term oxygen therapy (LTOT), Procedure: High Flow Nasal Therapy (HFNT)2 weeks of LTOT+HFNT then 2 weeks of LTOT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intertitial lung disease
- Persistant dyspnea (mMRC≥3)
- Long-term oxygen therapy at least for 3 months
Key exclusion criteria (10 listed)
- Chronic respiratory disease (COPD, lung cancer)
- Pneumothorax,
- Pneumomediastinum,
- Active smoker,
- Patient on non-invasive ventilation or continuous positive airway pressure (CPAP),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| long-term oxygen therapy (LTOT)Usual care with LTOT for 2 weeks | Procedure or surgery | High Flow Nasal Therapy (HFNT) then Long-Term Oxygen therapy (LTOT), Long-Term Oxygen therapy (LTOT) then High Flow Nasal Therapy (HFNT) |
| High Flow Nasal Therapy (HFNT)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 | Procedure or surgery | High Flow Nasal Therapy (HFNT) then Long-Term Oxygen therapy (LTOT), Long-Term Oxygen therapy (LTOT) then High Flow Nasal Therapy (HFNT) |
Primary outcome
SGRQ questionnaire : Saint George's Respiratory Questionnaire (symptom component)
Time frame: 2 weeks
Symptom component of SGRQ : Scores range from 0 to 100, with higher scores indicating more limitations.
28 secondary outcomes
Dyspnea assessement : dyspnoea-12
Time frame: 2 weeks
Dyspnea assessement : mMRC: Modified Medical Research Council
Time frame: 2 weeks
Dyspnea assessement : MDP: Multidimensional dyspnea profile
Time frame: 2 weeks
Quality of life (SGRQ questionnaire) : S.George's Respiratory Questionnaire
Time frame: 2 weeks
Quality of life (K-Bild) : The King's Brief Interstitial Lung Disease (KBILD) questionnaire
Time frame: 2 weeks
Quality of life questionnaire (SF12): Short Form 12
Time frame: 2 weeks
Anxiety-depression (HADS) : Hospital Anxiety and Depression scale
Time frame: 2 weeks
Distance at 6-minutes walk test
Time frame: 2 weeks
Dyspnea (Borg score) at the 6-minutes walk test
Time frame: 2 weeks
Number of rise at the 3-minutes rise chair test
Time frame: 2 weeks
Dyspnea (Borg score) at the 3-minutes rise chair test
Time frame: 2 weeks
Nocturnal capnography
Time frame: 2 weeks
Respiratory rate
Time frame: Over 2 weeks
Heart rate
Time frame: Over 2 weeks
SpO2
Time frame: Over 2 weeks
Rest
Time frame: Over 2 weeks
Activity
Time frame: Over 2 weeks
Activity
Time frame: Over 2 weeks
Sleep Quality only in patients for whom nocturnal polysomnography is performed during one night (optional)
Time frame: 2 weeks
Sleep Quality only in patients for whom nocturnal polysomnography is performed during one night (optional)
Time frame: 2 weeks
Sleep Quality only in patients for whom nocturnal polysomnography is performed during one night (optional)
Time frame: 2 weeks
Sleep Quality only in patients for whom nocturnal polysomnography is performed during one night (optional)
Time frame: 2 weeks
Sleep Quality only in patients for whom nocturnal polysomnography is performed during one night (optional)
Time frame: 2 weeks
Sleep Quality only in patients for whom nocturnal polysomnography is performed during one night (optional)
Time frame: 2 weeks
Sleep Quality only in patients for whom nocturnal polysomnography is performed during one night (optional)
Time frame: 2 weeks
Acute exacerbation and/or increase in resting oxygen flow
Time frame: 2 weeks
HFNT(High Flow Nasal Therapy) compliance
Time frame: 2 weeks
HFNT (High Flow Nasal Therapy) acceptability
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatiqueet des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Capucine Morélot-Panzini, MD,PhD, Prof principal investigator
APHP • Assistance Publique des hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing long-term oxygen therapy (LTOT) and High Flow Nasal Therapy (HFNT) in people with ILD, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Capucine Morélot-Panzini, MD,PhD, Prof (0142167771, capucine.morelot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SGRQ questionnaire : Saint George's Respiratory Questionnaire (symptom component) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.