Palliative CareHFNTpalNCT07552935
Management of Dyspnea With High- Flow Nasal Therapy
A study testing High-flow nasal therapy and Airflow directed to face by a fan in people with Palliative Care and Breathlessness, run by Tampere University Hospital at 2 sites in Finland.
Trial summary
Dyspnea in patients with incurable illness is a difficult symptom. Therefore, there is a need to identify new effective treatment modalities. Previous studies suggest that high-flow nasal therapy delivered via a nasal cannula (HFNT = High-Flow Nasal Therapy) may alleviate dyspnea, and similarly that directing airflow… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Breathlessness
- What is being tested?
- High-flow nasal therapy and Airflow directed to face by a fan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFinland
- Study dates
- 1 Jun 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- The patient is in palliative care (ICD-10 diagnostic code Z51.5 palliative care)
- Age ≥ 18 years
- Ability to understand the study and provide informed consent to participate
- Significant breathlessness (NRS = Numeric Rating Scale ≥ 4).
- The treating physician has assessed that the patient would not benefit from treatment in intensive care unit or monitor unit.
- The treating physician has assessed that the patient would not benefit from invasive mechanical ventilation (intubation) or cardiopulmonary resuscitation.
Who cannot join
- Decreased level of consciousness, delirium, or other lack of cooperation that prevents participation.
- Respiratory support other than HFNT is required.
- The patient has received HFNT during the same admission to palliative care ward or hospice.
- The cause of dyspnea can be treated immediately.
- Inability to provide informed consent to participate.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites, 2 recruiting
- Recruiting
Pirkanmaa Hospice
Tampere, 33520
Juho Lehto, Professor, +358 50 4090974, juho.lehto@tuni.fi
Sirpa Leivo-Korpela, MD, PhD, + 358 44 485 8055, sirpa.leivo-korpela@pirha.fi
- Recruiting
Hatanpää hospital, Palliative Care Centre and Home Hospital Services, Wellbeing Services County of Pirkanmaa, Tampere University Hospital
Tampere, 33900
Sirpa Leivo-Korpela, MD, PhD, + 358 44 485 8055, sirpa.leivo-korpela@pirha.fi
Juho Lehto, MD, PhD, Professor, juho.lehto@tuni.fi
About this study
Dyspnea in patients with incurable illness is a difficult symptom. Therefore, there is a need to identify new effective treatment modalities. Previous studies suggest that high-flow nasal therapy delivered via a nasal cannula (HFNT = High-Flow Nasal Therapy) may alleviate dyspnea, and similarly that directing airflow toward the face can provide relief. HFNT has been studied very little in hospice settings and on palliative care wards. The aim of this study is to determine whether HFNT is a feasible and effective treatment for relieving dyspnea in patients receiving palliative care.
Patients will be recruited from the Hatanpää Palliative Care Ward and the Pirkanmaa Hospice, Tampere, Finland. The target is to recruit approximately 30-40 patients. The inclusion criteria are: age ≥18 years, ability to understand the study and provide informed consent to participate, a palliative treatment approach, and significant dyspnea.
Read more
Each patient receives HFNT and fan therapy in which airflow will be directed toward the patient's face. Both treatments will last 30 minutes. Patient symptoms will be asked after the treatments. In addition, patients will be asked to rate the overall benefit they experienced from the intervention and any side effects. The primary endpoint is the relief of dyspnea with HFNT compared with fan therapy.
The study will be conducted in accordance with laws, regulations, and guidelines governing medical research, as well as good scientific practice and research ethics. The study does not involve significant risks or measurements or sampling procedures that would cause additional discomfort. All other care for the patient will be provided according to the standard practices of the treating unit, and participation in the study will not limit any necessary treatments. Identifiable information will not be disclosed for use outside the research group. Results will be reported in a manner that does not allow patients to be identified. The Ethics Committee of the Wellbeing Services County of Pirkanmaa has approved the study.
If successful, the study will significantly improve the care of the patients in palliative care.
Read the detailed description
Management of Dyspnea with High-Flow Nasal Therapy
Dyspnea in patients with incurable illness is a difficult-to-manage symptom that markedly impairs quality of life. Especially toward the end of life, the severity of dyspnea increases and the response to treatments decreases. Frail patients often tolerate mask-based therapies poorly. Therefore, there remains a need to identify new effective treatment modalities. Previous studies suggest that high-flow nasal therapy delivered via a nasal cannula (HFNT = High-Flow Nasal Therapy) may alleviate dyspnea in cancer patients, and similarly that directing airflow toward the face can provide relief. HFNT has been studied very little in hospice settings and on palliative care wards. The aim of this study is to determine whether HFNT is a feasible and effective treatment for relieving dyspnea in patients receiving palliative care in the care settings where these patients are usually treated.
Patients will be recruited from the Hatanpää Palliative Care Ward and the Pirkanmaa Hospice, Tampere, Finland. The target is to recruit approximately 30-40 patients. The inclusion criteria are: age ≥18 years, ability to understand the study and provide informed consent to participate, a palliative treatment approach, and significant dyspnea defined as ≥4 on the NRS (Numerical Rating Scale). Patients will be offered the opportunity to participate in the study and will be provided with written materials, including the study information sheet and consent form, for review. Patients will be given sufficient time to consider participation. Those who choose to participate will provide written informed consent.
The study will be conducted using a crossover design in which each patient receives two treatment interventions. In one intervention, the patient will receive HFNT, and in the other, airflow will be directed toward the patient's face using a fan. Supplemental oxygen will be used if the patient requires it. Each intervention will last 30 minutes. Patient symptoms will be asked using the NRS scale before and after the interventions. In addition, patients will be asked to rate the overall benefit they experienced from the intervention and any side effects. The primary endpoint is the change in dyspnea on the NRS scale with HFNT compared with fan therapy. Based on the sample size calculation, the total number of patients required is approximately 30-40.
The study will be conducted in accordance with laws, regulations, and guidelines governing medical research, as well as good scientific practice and research ethics. The study does not involve significant risks or measurements or sampling procedures that would cause additional discomfort. All other care for the patient will be provided according to the standard practices of the treating unit, and participation in the study will not limit any necessary treatments. Study data will be stored confidentially in accordance with the data protection statement. Data containing direct or indirect identifiers and code keys will be destroyed after completion of the study. Fully anonymized data will be archived securely, as it may be needed for meta-analyses of similar studies. Identifiable information will not be disclosed for use outside the research group. Results will be reported in a manner that does not allow individual patients or their relatives to be identified. The Ethics Committee of the Wellbeing Services County of Pirkanmaa has approved the study (R26040).
If successful, the study will significantly improve the care of the patients in palliative care and help to alleviate their suffering.
- Conditions
- Palliative Care, Breathlessness
- Being tested
- High-flow nasal therapy, Airflow directed to face by a fan
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal therapyDevice
A high-flow nasal therapy for 30 minutes.
Airflow directed to face by a fanDevice
Airflow directed to face by a fan for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group A, HFNT first | Active comparator | Patients use high-flow nasal therapy first and the fan thereafter Receives: Device: High-flow nasal therapy; Device: Airflow directed to face by a fan |
| Group B, Fan first | Active comparator | Patients use the fan first and high-flow nasal therapy thereafter Receives: Device: High-flow nasal therapy; Device: Airflow directed to face by a fan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breathlessness with HFNT compared with fan therapy
Change in the breathlessness measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness) by the HFNT compared to the change in the breathlessness measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness) by fan therapy.
Measured: Measurements are made immediately before and immediately after the treatment period.
Secondary outcomes (12)
Change in breathlessness before and after treatments
Change in the breathlessness measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness) by HFNT and fan therapy
Measured: Measurements are made immediately before and immediately after the treatment period.
Breathlessness after the HFNT compared to fan therapy
Breathlessness measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness) after the HFNT compared to fan therapy.
Measured: Measurements are made immediately after the treatment periods.
Proportion of patients reporting 1 or more points decrease in NRS scale for breathlessness by the treatments
Proportion of patients reporting 1 or more points decrease in numeric rating scale (NRS) for breathlessness from 0 (no breathlessness) to 10 (the worst possible breathlessness) by the HFNT and fan therapy.
Measured: Measurements are made immediately before and immediately after the treatment period.
Change in cough, respiratory secretions, mouth dryness, pain and anxiety before and after the treatments
Change in cough, respiratory secretions, mouth dryness, pain and anxiety measured by numeric rating scale (NRS) from 0 (no symptom) to 10 (the worst possible symptom) by HFNT and fan therapy.
Measured: Measurements are made immediately before and immediately after the treatment period.
Change in respiratory frequency with the treatments
Change in respiratory frequency measured by calculating breaths per minute before and after HFNT and fan therapy.
Measured: Measurements are made immediately before and immediately after the treatment period.
Change in oxygen saturation with the treatments
Change in peripheral oxygen saturation (%) measured with pulse oximeter before and after the HFNT and fan therapy.
Measured: Measurements are made immediately before and immediately after the treatment period.
Change in heart rate with the treatments
Change in heart rate measured by calculating heart beats per minute before and after the HFNT and fan therapy.
Measured: Measurements are made immediately before and immediately after the treatment period
Proportion of patients reporting to have overall benefit of the treatments
Proportion of patients reporting to have overall benefit of the HFNT and fan therapy
Measured: Opinion is asked immediately after the treatments
Proportion of patients who report side-effects of the treatments
Proportion of patients who report side-effects of the HFNT and fan therapy
Measured: Experienced side-effects are asked immediately after the treatments
Proportion of patients not complying with the treatments
Proportion of patients not complying with the HFNT and fan therapy
Measured: Compliance is measured immediately after the treatment periods
Proportion of patients preferring HFNT over fan therapy
Proportion of patients preferring HFNT over fan therapy
Measured: Preference is asked immediately after both interventions have been performed
Proportion of patients preferring HFNT over conventional oxygen therapy
In patients, who have used conventional oxygen therapy, the proportion of patients preferring HFNT over conventional oxygen therapy is measured.
Measured: Preference is asked immediately after the HFNT intervention, if the patient have used conventional oxygen therapy before the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 Jun 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juho Lehto, Tampere University Hospital
- Investigators
- Juho Lehto, Professor, Principal investigator, Tampere University Hospital and Tampere University, Tampere, Finland.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552935
- Sponsor's protocol ID
- R26040
- Acronym
- HFNTpal
- Status last verified
- Jun 2026
- First submitted
- 15 Apr 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous data will be available from the Central Contact Person upon a reasonable request after the study have been completed.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Dyspnea With High- Flow Nasal Therapy
- ClinicalTrials.gov ID
- NCT07552935
- Acronym / sponsor ID
- HFNTpal / R26040
- Conditions
- Palliative Care, Breathlessness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Apr 2026 (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.
Dyspnea in patients with incurable illness is a difficult symptom. Therefore, there is a need to identify new effective treatment modalities. Previous studies suggest that high-flow nasal therapy delivered via a nasal cannula (HFNT = High-Flow Nasal Therapy) may alleviate dyspnea, and similarly that directing airflow toward the face can provide relief. HFNT has been studied very little in hospice settings and on palliative care wards. The aim of this study is to determine whether HFNT is a feasible and effective treatment for relieving dyspnea in patients receiving palliative care.
Patients will be recruited from the Hatanpää Palliative Care Ward and the Pirkanmaa Hospice, Tampere, Finland. The target is to recruit approximately 30-40 patients. The inclusion criteria are: age ≥18 years, ability to understand the study and provide informed consent to participate, a palliative treatment approach, and significant dyspnea.
Each patient receives HFNT and fan therapy in which airflow will be directed toward the patient's face. Both treatments will last 30 minutes. Patient symptoms will be asked after the treatments. In addition, patients will be asked to rate the overall benefit they experienced from the intervention and any side effects. The primary endpoint is the relief of dyspnea with HFNT compared with fan therapy.
The study will be conducted in accordance with laws, regulations, and guidelines governing medical research, as well as good scientific practice and research ethics. The study does not involve significant risks or measurements or sampling procedures that would cause additional discomfort. All other care for the patient will be provided according to the standard practices of the treating unit, and participation in the study will not limit any necessary treatments. Identifiable information will not be disclosed for use outside the research group. Results will be reported in a manner that does not allow patients to be identified. The Ethics Committee of the Wellbeing Services County of Pirkanmaa has approved the study.
If successful, the study will significantly improve the care of the patients in palliative care.
Detailed description
Management of Dyspnea with High-Flow Nasal Therapy
Dyspnea in patients with incurable illness is a difficult-to-manage symptom that markedly impairs quality of life. Especially toward the end of life, the severity of dyspnea increases and the response to treatments decreases. Frail patients often tolerate mask-based therapies poorly. Therefore, there remains a need to identify new effective treatment modalities. Previous studies suggest that high-flow nasal therapy delivered via a nasal cannula (HFNT = High-Flow Nasal Therapy) may alleviate dyspnea in cancer patients, and similarly that directing airflow toward the face can provide relief. HFNT has been studied very little in hospice settings and on palliative care wards. The aim of this study is to determine whether HFNT is a feasible and effective treatment for relieving dyspnea in patients receiving palliative care in the care settings where these patients are usually treated.
Patients will be recruited from the Hatanpää Palliative Care Ward and the Pirkanmaa Hospice, Tampere, Finland. The target is to recruit approximately 30-40 patients. The inclusion criteria are: age ≥18 years, ability to understand the study and provide informed consent to participate, a palliative treatment approach, and significant dyspnea defined as ≥4 on the NRS (Numerical Rating Scale). Patients will be offered the opportunity to participate in the study and will be provided with written materials, including the study information sheet and consent form, for review. Patients will be given sufficient time to consider participation. Those who choose to participate will provide written informed consent.
The study will be conducted using a crossover design in which each patient receives two treatment interventions. In one intervention, the patient will receive HFNT, and in the other, airflow will be directed toward the patient's face using a fan. Supplemental oxygen will be used if the patient requires it. Each intervention will last 30 minutes. Patient symptoms will be asked using the NRS scale before and after the interventions. In addition, patients will be asked to rate the overall benefit they experienced from the intervention and any side effects. The primary endpoint is the change in dyspnea on the NRS scale with HFNT compared with fan therapy. Based on the sample size calculation, the total number of patients required is approximately 30-40.
The study will be conducted in accordance with laws, regulations, and guidelines governing medical research, as well as good scientific practice and research ethics. The study does not involve significant risks or measurements or sampling procedures that would cause additional discomfort. All other care for the patient will be provided according to the standard practices of the treating unit, and participation in the study will not limit any necessary treatments. Study data will be stored confidentially in accordance with the data protection statement. Data containing direct or indirect identifiers and code keys will be destroyed after completion of the study. Fully anonymized data will be archived securely, as it may be needed for meta-analyses of similar studies. Identifiable information will not be disclosed for use outside the research group. Results will be reported in a manner that does not allow individual patients or their relatives to be identified. The Ethics Committee of the Wellbeing Services County of Pirkanmaa has approved the study (R26040).
If successful, the study will significantly improve the care of the patients in palliative care and help to alleviate their suffering.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A, HFNT first | Active comparator | Device: High-flow nasal therapy, Device: Airflow directed to face by a fanPatients use high-flow nasal therapy first and the fan thereafter |
| Group B, Fan first | Active comparator | Device: High-flow nasal therapy, Device: Airflow directed to face by a fanPatients use the fan first and high-flow nasal therapy thereafter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient is in palliative care (ICD-10 diagnostic code Z51.5 palliative care)
- Age ≥ 18 years
- Ability to understand the study and provide informed consent to participate
- Significant breathlessness (NRS = Numeric Rating Scale ≥ 4).
- The treating physician has assessed that the patient would not benefit from treatment in intensive care unit or monitor unit.
Key exclusion criteria (5 listed)
- Decreased level of consciousness, delirium, or other lack of cooperation that prevents participation.
- Respiratory support other than HFNT is required.
- The patient has received HFNT during the same admission to palliative care ward or hospice.
- The cause of dyspnea can be treated immediately.
- Inability to provide informed consent to participate.
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 |
|---|---|---|
| High-flow nasal therapyA high-flow nasal therapy for 30 minutes. | Device | Group A, HFNT first, Group B, Fan first |
| Airflow directed to face by a fanAirflow directed to face by a fan for 30 minutes | Device | Group A, HFNT first, Group B, Fan first |
Primary outcome
Change in breathlessness with HFNT compared with fan therapy
Time frame: Measurements are made immediately before and immediately after the treatment period.
Change in the breathlessness measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness) by the HFNT compared to the change in the breathlessness measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness) by fan therapy.
12 secondary outcomes
Change in breathlessness before and after treatments
Time frame: Measurements are made immediately before and immediately after the treatment period.
Breathlessness after the HFNT compared to fan therapy
Time frame: Measurements are made immediately after the treatment periods.
Proportion of patients reporting 1 or more points decrease in NRS scale for breathlessness by the treatments
Time frame: Measurements are made immediately before and immediately after the treatment period.
Change in cough, respiratory secretions, mouth dryness, pain and anxiety before and after the treatments
Time frame: Measurements are made immediately before and immediately after the treatment period.
Change in respiratory frequency with the treatments
Time frame: Measurements are made immediately before and immediately after the treatment period.
Change in oxygen saturation with the treatments
Time frame: Measurements are made immediately before and immediately after the treatment period.
Change in heart rate with the treatments
Time frame: Measurements are made immediately before and immediately after the treatment period
Proportion of patients reporting to have overall benefit of the treatments
Time frame: Opinion is asked immediately after the treatments
Proportion of patients who report side-effects of the treatments
Time frame: Experienced side-effects are asked immediately after the treatments
Proportion of patients not complying with the treatments
Time frame: Compliance is measured immediately after the treatment periods
Proportion of patients preferring HFNT over fan therapy
Time frame: Preference is asked immediately after both interventions have been performed
Proportion of patients preferring HFNT over conventional oxygen therapy
Time frame: Preference is asked immediately after the HFNT intervention, if the patient have used conventional oxygen therapy before the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes. Anonymous data will be available from the Central Contact Person upon a reasonable request after the study have been completed.
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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.
Juho Lehto, Professor principal investigator
Tampere University Hospital and Tampere University, Tampere, Finland.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow nasal therapy and Airflow directed to face by a fan in people with Palliative Care and Breathlessness, run by Tampere University Hospital at 2 sites in Finland.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juho Lehto, Professor (+358 50 4090974, juho.lehto@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in breathlessness with HFNT compared with fan therapy (time frame: Measurements are made immediately before and immediately after the treatment period.). 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 30 Jun 2026.