BreathlessnessNCT05257850
Management of Breathlessness with High-flow Nasal Therapy or a Fan
A study testing High-flow nasal therapy and Airflow directed to face by a fan in people with Breathlessness and Cancer, run by Tampere University Hospital at 2 sites in Finland.
Trial summary
Airflow directed to the face by a fan is shown to relief breathlessness in palliative care and some studies have suggested High-Flow nasal airflow therapy beneficial as well. However, these two treatments have not been compared. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breathlessness, Cancer
- 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
- 36 participants
- Where
- 2 sitesFinland
- Study dates
- 26 Apr 2022to 31 Dec 2024
- 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
- Advanced cancer
- At least 18 years of age
- Breathlessness (At least 3 on a NRS-scale from 0 to 10)
- Capable to understand the study and to give informed consent
- Do not benefit from ICU treatment or resuscitation defined by the physician taking care of the patient
Who cannot join
- Insufficient co-operation for the study treatment or to give informed consent
- Oxygen saturation under 88 % on room air
- Need for other device to treat the breathlessness
- The reason of breathlessness can be immediately treated
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Pirkanmaa Hospice
Tampere, 33520
Tampere University Hospital
Tampere, 33520
About this study
Airflow directed to the face by a fan is shown to relief breathlessness in palliative care and some studies have suggested High-Flow nasal airflow therapy beneficial as well. However, these two treatments have not been compared.
40 patients with advanced cancer and breathlessness are recruited from Tampere University Hospital or Pirkanmaa Hospice. All patients are treated with two therapies: 1. High-Flow nasal airflow therapy with a nasal cannula and 2. airflow directed to the face by a fan. Both treatment periods last 30 minutes or as long as the patient wish to use the therapy. The effects of the therapies on breathlessness are compared by asking the subjective relief of breathlessness after each therapies. The study do not limit any other therapies used in the normal clinical care for the patients. Thus, all the other therapies the physicians taking care of the patient orders are permitted. Hopefully, the patients achieve relief for their breathlessness through the study treatments given in addition to their normal treatment. There are no significant risks related to the therapies, but they may cause some inconveniences such as mouth dryness. These possible side-effects of the therapies are asked as well.
Read the detailed description
Airflow directed to the face by a fan is shown to relief breathlessness in palliative care and some studies have suggested High-Flow nasal airflow therapy beneficial as well. However, these two treatments have not been compared and High-Flow nasal airflow therapy has not been tested in the context of hospice.
40 patients over 18 years with advanced cancer and breathlessness are recruited from Tampere University Hospital or Pirkanmaa Hospice. All patients are treated with two therapies: 1. High-Flow nasal airflow therapy with a nasal cannula and 2. airflow directed to the face by a fan (crossover trial). Both treatment periods last 30 minutes or as long as the patient wish to use the therapy. The effects of the therapies on breathlessness are compared by asking the subjective relief of breathlessness after each therapies with numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness). Influence of the treatments on anxiety, pain and mouth dryness are measured as well with numeric rating scale (NRS) from 0 to 10. The study do not limit any other therapies used in the normal clinical care for the patients. Thus, all the other therapies the physicians taking care of the patient orders are permitted. Hopefully, the patients achieve relief for their breathlessness through the study treatments given in addition to their normal treatment. There are no significant risks related to the therapies, but they may cause some inconveniences such as mouth dryness. These possible side-effects of the therapies are asked as well.
- Conditions
- Breathlessness, Cancer
- Being tested
- High-flow nasal therapy, Airflow directed to face by a fan
- Medical subject headings
- Dyspnea, Neoplasms
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
A fan directed to the face for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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 |
| High-flow nasal therapy 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathlessness after the study treatments (difference between the High-Flow Nasal Therapy and a fan)
The breathlessness after the study treatments measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness).
Measured: Measurements are made immediately before and immediately after the treatment period.
Secondary outcomes (9)
Change in breathlessness before and after the treatments
Change in breathlessness before and after the treatments measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness).
Measured: Measurements are made immediately before and immediately after the treatment period.
Change in mouth dryness before and after the treatments
Change in mouth dryness before and after the treatments measured by numeric rating scale (NRS) from 0 (no mouth dryness) to 10 (the worst possible mouth dryness).
Measured: Measurements are made immediately before and immediately after the treatment period.
Change in anxiety before and after the treatments
Change in anxiety before and after the treatments measured by numeric rating scale (NRS) from 0 (no anxiety) to 10 (the worst possible anxiety).
Measured: Measurements are made immediately before and immediately after the treatment period.
Change in pain before and after the treatments
Change in pain before and after the treatments measured by numeric rating scale (NRS) from 0 (no pain) to 10 (the worst possible pain).
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.
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.
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.
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 treatments
Measured: Opinion is asked immediately after the treatment
Proportion of patients who report side-effects of the treatments
Proportion of patients who report side-effects of the treatments
Measured: Experienced side-effects are asked immediately after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start26 Apr 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreathlessnessStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- 36 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257850
- Sponsor's protocol ID
- R20049
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2022
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leivo-Korpela S, Rantala HA, Lehtimaki L, Piili RP, Hasala H, Korhonen T, Lehto JT. Management of Dyspnea With High-Flow Nasal Air or Fan-A Randomized Controlled Crossover Trial. J Pain Symptom Manage. 2026 Jan;71(1):8-15. doi: 10.1016/j.jpainsymman.2025.08.033. Epub 2025 Sep 4.
PubMed 40914402
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Breathlessness with High-flow Nasal Therapy or a Fan
- ClinicalTrials.gov ID
- NCT05257850
- Acronym / sponsor ID
- R20049
- Conditions
- Breathlessness, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 Feb 2022 (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.
Airflow directed to the face by a fan is shown to relief breathlessness in palliative care and some studies have suggested High-Flow nasal airflow therapy beneficial as well. However, these two treatments have not been compared.
40 patients with advanced cancer and breathlessness are recruited from Tampere University Hospital or Pirkanmaa Hospice. All patients are treated with two therapies: 1. High-Flow nasal airflow therapy with a nasal cannula and 2. airflow directed to the face by a fan. Both treatment periods last 30 minutes or as long as the patient wish to use the therapy. The effects of the therapies on breathlessness are compared by asking the subjective relief of breathlessness after each therapies. The study do not limit any other therapies used in the normal clinical care for the patients. Thus, all the other therapies the physicians taking care of the patient orders are permitted. Hopefully, the patients achieve relief for their breathlessness through the study treatments given in addition to their normal treatment. There are no significant risks related to the therapies, but they may cause some inconveniences such as mouth dryness. These possible side-effects of the therapies are asked as well.
Detailed description
Airflow directed to the face by a fan is shown to relief breathlessness in palliative care and some studies have suggested High-Flow nasal airflow therapy beneficial as well. However, these two treatments have not been compared and High-Flow nasal airflow therapy has not been tested in the context of hospice.
40 patients over 18 years with advanced cancer and breathlessness are recruited from Tampere University Hospital or Pirkanmaa Hospice. All patients are treated with two therapies: 1. High-Flow nasal airflow therapy with a nasal cannula and 2. airflow directed to the face by a fan (crossover trial). Both treatment periods last 30 minutes or as long as the patient wish to use the therapy. The effects of the therapies on breathlessness are compared by asking the subjective relief of breathlessness after each therapies with numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness). Influence of the treatments on anxiety, pain and mouth dryness are measured as well with numeric rating scale (NRS) from 0 to 10. The study do not limit any other therapies used in the normal clinical care for the patients. Thus, all the other therapies the physicians taking care of the patient orders are permitted. Hopefully, the patients achieve relief for their breathlessness through the study treatments given in addition to their normal treatment. There are no significant risks related to the therapies, but they may cause some inconveniences such as mouth dryness. These possible side-effects of the therapies are asked as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
| High-flow nasal therapy 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Advanced cancer
- At least 18 years of age
- Breathlessness (At least 3 on a NRS-scale from 0 to 10)
- Capable to understand the study and to give informed consent
- Do not benefit from ICU treatment or resuscitation defined by the physician taking care of the patient
Key exclusion criteria (4 listed)
- Insufficient co-operation for the study treatment or to give informed consent
- Oxygen saturation under 88 % on room air
- Need for other device to treat the breathlessness
- The reason of breathlessness can be immediately treated
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 | Fan first, High-flow nasal therapy first |
| Airflow directed to face by a fanA fan directed to the face for 30 minutes | Device | Fan first, High-flow nasal therapy first |
Primary outcome
Breathlessness after the study treatments (difference between the High-Flow Nasal Therapy and a fan)
Time frame: Measurements are made immediately before and immediately after the treatment period.
The breathlessness after the study treatments measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness).
9 secondary outcomes
Change in breathlessness before and after the treatments
Time frame: Measurements are made immediately before and immediately after the treatment period.
Change in mouth dryness before and after the treatments
Time frame: Measurements are made immediately before and immediately after the treatment period.
Change in anxiety before and after the treatments
Time frame: Measurements are made immediately before and immediately after the treatment period.
Change in pain 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 heart rate 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.
Proportion of patients reporting to have overall benefit of the treatments
Time frame: Opinion is asked immediately after the treatment
Proportion of patients who report side-effects of the treatments
Time frame: Experienced side-effects are asked immediately after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Derived from this study: PubMed 40914402Leivo-Korpela S, Rantala HA, Lehtimaki L, Piili RP, Hasala H, Korhonen T, Lehto JT. Management of Dyspnea With High-Flow Nasal Air or Fan-A Randomized Controlled Crossover Trial. J Pain Symptom Manage. 2026 Jan;71(1):8-15. doi: 10.1016/j.jpainsymman.2025.08.033. Epub 2025 Sep 4.
- Individual participant dataSharing planned: No
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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.
Juho Lehto, Professor principal investigator
Tampere University Hospital
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 Breathlessness and Cancer, 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 31 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathlessness after the study treatments (difference between the High-Flow Nasal Therapy and a fan) (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?
On the ClinicalTrials.gov record for NCT05257850, which also lists 1 linked publication.
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 31 Jan 2025.