Type 2 Diabetes Mellitus (T2DM)NCT07103460
Essential Oil-Assisted Respiratory Training in Type 2 Diabetic Patients With Lung Infections
A study testing Essential Oil Diffusion Combined with Respiratory Training in people with Type 2 Diabetes Mellitus (T2DM) and Pulmonary Infections, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
Previous studies have shown that baseline pulmonary function in patients with type 2 diabetes mellitus (T2DM) is approximately 8% to 10% lower than in healthy individuals. Under similar infection conditions, respiratory function impairment is more pronounced in T2DM patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Pulmonary Infections, Pneumonia
- What is being tested?
- Essential Oil Diffusion Combined with Respiratory Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Jul 2025to 31 Jul 2027
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently hospitalized due to pulmonary infection (ICD-10 codes: J00.x to J22.x).
- Diagnosed with type 2 diabetes mellitus (ICD-10 codes: E10.x or E11.x). III. Aged between 18 and 90 years. IV. Able to communicate verbally or non-verbally and understand Mandarin or Taiwanese.
- Willing to participate in the study and consent to group assignment.
Who cannot join
- Modified Rankin Scale (mRS) score ≥ 5, indicating severe functional impairment.
- Diagnosed with dementia (unable to comprehend or follow intervention instructions).
- Presence of acute psychiatric symptoms that impair communication. IV. Individuals with high litigation risk. V. Diagnosed with chronic obstructive pulmonary disease (COPD) or any other chronic respiratory diseases.
- Diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency (ICD-10 codes: D55.x, D74-75.x).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Tri-Service General Hospital Songshan Branch
Taipei
Yao-Hsiang Chen, +886287923311, 810792me@gmail.com
About this study
Official title: The Effect of Essential Oil Diffusion Combined With Respiratory Training on the Respiratory Function of Patients With Acute Pulmonary Infections and Type 2 Diabetes
Previous studies have shown that baseline pulmonary function in patients with type 2 diabetes mellitus (T2DM) is approximately 8% to 10% lower than in healthy individuals. Under similar infection conditions, respiratory function impairment is more pronounced in T2DM patients. Therefore, this project aims to explore the effects of incentive spirometry (IS) respiratory training combined with an essential oil diffusion device on improving respiratory function in T2DM patients. Over next two years, this study will utilize data from medical history, blood examination, cardiopulmonary endurance evaluations, subjective respiratory symptom assessments, and pulmonary function analyses to demonstrate the improving effect of the intervention in the patients with T2DM and pulmonary infection. In the first year, the study will focus on assessing the improvement in respiratory function among T2DM patients with concurrent pulmonary infections following IS respiratory training. In the second year, three commonly used essential oils (wintergreen, peppermint, and eucalyptus) will be integrated into IS respiratory training. The goal is to enhance patient comfort during training while improving the effectiveness of respiratory training and investigating the mechanisms and effects of different essential oils. The expected outcomes of this study include demonstrating that IS respiratory training combined with an essential oil diffusion device developed by our research team, could more effectively improve the respiratory function of T2DM patients with pulmonary infections. Building on this foundation, the project aims to increase patient comfort during training sessions by incorporating three commonly available essential oils-wintergreen, peppermint, and eucalyptus. This approach is expected to enhance patient acceptance of respiratory training interventions, laying a solid foundation for clinical promotion. Additionally, the study will analyze the differential effects of these essential oils on respiratory function improvement, providing a cornerstone for future clinical research in the fields of chemistry,
- Being tested
- Essential Oil Diffusion Combined with Respiratory Training
- Medical subject headings
- Diabetes Mellitus, Type 2, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential Oil Diffusion Combined with Respiratory TrainingCombination product
three commonly used essential oils (wintergreen, peppermint, and eucalyptus) will be integrated into IS respiratory training
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Not described Receives: Combination Product: Essential Oil Diffusion Combined with Respiratory Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting sugar (mg/dl)
A fasting blood sugar test measures the amount of glucose in blood after you haven't eaten for at least 8 hours. The test is typically performed first thing in the morning before breakfast.
Measured: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)
Glycated Hemoglobin; HbA1c (%)
Glycated hemoglobin, also known as HbA1c, is a blood test that reflects average blood sugar levels over the past 2-3 months. It measures the percentage (%) of red blood cells coated with glucose (sugar).
Measured: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)
Oxyhemoglobin saturation by pulse oximetry; SpO2 (%)
SpO2, or peripheral oxygen saturation, is the percentage of hemoglobin in blood that is carrying oxygen, as measured by a pulse oximeter. It's a non-invasive way to estimate how much oxygen is in blood, with normal levels typically ranging from 95-100%.
Measured: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)
Hemoglobin; Hb(g/dL)
Hemoglobin (Hb) is a protein found in red blood cells that carries oxygen throughout the body. The amount of hemoglobin in the blood is measured and expressed in grams per deciliter (g/dL).
Measured: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)
lactate(mmol/L)
Lactate, also known as lactic acid, is a molecule produced during the breakdown of glucose for energy, particularly when oxygen is limited.
The common unit for lactate is millimoles per liter (mmol/L). In clinical tests, lactate concentration is usually expressed in this unit.
Measured: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)
Dyspnea-12 score; D-12
D-12-C scale was developed, which demonstrated satisfactory reliability and validity in measuring dyspnoea among COPD patients.D-12 consists of 12 descriptor items on a scale of none (0), mild (1), moderate (2), or severe (3). Higher scores indicate more severe dyspnea.
Measured: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)
Pulmonary function test-PEF (peak expiratory flow)(L/min)
Peak expiratory flow (PEF) or peak expiratory flow rate (PEFR) measures how quickly you can blow air out of your lungs. It's a way to assess how well your lungs are working, particularly for those with asthma or other lung conditions. A peak flow meter, a handheld device, is used to measure it.
Measured: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)
lung function test- FEV1(Forced expiratory volume in the first second ) (L)
FEV1, or Forced Expiratory Volume in 1 second, is a measurement used in lung function tests, specifically spirometry. It represents the amount of air a person can forcefully exhale in the first second of a forced exhalation after taking a deep breath. The unit for FEV1 is liters (L)
Measured: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start25 Jul 2025 (estimated)
- Primary completion25 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Shan Hsieh, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103460
- Sponsor's protocol ID
- B2023051651
- Status last verified
- Jul 2025
- First submitted
- 19 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Essential Oil Diffusion Combined With Respiratory Training on the Respiratory Function of Patients With Acute Pulmonary Infections and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07103460
- Acronym / sponsor ID
- B2023051651
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 25 Jul 2025 (estimated)
- Primary completion
- 25 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 5 Aug 2025 (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.
Previous studies have shown that baseline pulmonary function in patients with type 2 diabetes mellitus (T2DM) is approximately 8% to 10% lower than in healthy individuals. Under similar infection conditions, respiratory function impairment is more pronounced in T2DM patients. Therefore, this project aims to explore the effects of incentive spirometry (IS) respiratory training combined with an essential oil diffusion device on improving respiratory function in T2DM patients. Over next two years, this study will utilize data from medical history, blood examination, cardiopulmonary endurance evaluations, subjective respiratory symptom assessments, and pulmonary function analyses to demonstrate the improving effect of the intervention in the patients with T2DM and pulmonary infection. In the first year, the study will focus on assessing the improvement in respiratory function among T2DM patients with concurrent pulmonary infections following IS respiratory training. In the second year, three commonly used essential oils (wintergreen, peppermint, and eucalyptus) will be integrated into IS respiratory training. The goal is to enhance patient comfort during training while improving the effectiveness of respiratory training and investigating the mechanisms and effects of different essential oils. The expected outcomes of this study include demonstrating that IS respiratory training combined with an essential oil diffusion device developed by our research team, could more effectively improve the respiratory function of T2DM patients with pulmonary infections. Building on this foundation, the project aims to increase patient comfort during training sessions by incorporating three commonly available essential oils-wintergreen, peppermint, and eucalyptus. This approach is expected to enhance patient acceptance of respiratory training interventions, laying a solid foundation for clinical promotion. Additionally, the study will analyze the differential effects of these essential oils on respiratory function improvement, providing a cornerstone for future clinical research in the fields of chemistry,
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Combination Product: Essential Oil Diffusion Combined with Respiratory Training |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently hospitalized due to pulmonary infection (ICD-10 codes: J00.x to J22.x).
- Diagnosed with type 2 diabetes mellitus (ICD-10 codes: E10.x or E11.x). III. Aged between 18 and 90 years. IV. Able to communicate verbally or non-verbally and understand Mandarin or Taiwanese.
- Willing to participate in the study and consent to group assignment.
Key exclusion criteria (4 listed)
- Modified Rankin Scale (mRS) score ≥ 5, indicating severe functional impairment.
- Diagnosed with dementia (unable to comprehend or follow intervention instructions).
- Presence of acute psychiatric symptoms that impair communication. IV. Individuals with high litigation risk. V. Diagnosed with chronic obstructive pulmonary disease (COPD) or any other chronic respiratory diseases.
- Diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency (ICD-10 codes: D55.x, D74-75.x).
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 |
|---|---|---|
| Essential Oil Diffusion Combined with Respiratory Trainingthree commonly used essential oils (wintergreen, peppermint, and eucalyptus) will be integrated into IS respiratory training | Combination product | treatment group |
Primary outcome
fasting sugar (mg/dl)
Time frame: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)
A fasting blood sugar test measures the amount of glucose in blood after you haven't eaten for at least 8 hours. The test is typically performed first thing in the morning before breakfast.
Glycated Hemoglobin; HbA1c (%)
Time frame: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)
Glycated hemoglobin, also known as HbA1c, is a blood test that reflects average blood sugar levels over the past 2-3 months. It measures the percentage (%) of red blood cells coated with glucose (sugar).
Oxyhemoglobin saturation by pulse oximetry; SpO2 (%)
Time frame: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)
SpO2, or peripheral oxygen saturation, is the percentage of hemoglobin in blood that is carrying oxygen, as measured by a pulse oximeter. It's a non-invasive way to estimate how much oxygen is in blood, with normal levels typically ranging from 95-100%.
Hemoglobin; Hb(g/dL)
Time frame: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)
Hemoglobin (Hb) is a protein found in red blood cells that carries oxygen throughout the body. The amount of hemoglobin in the blood is measured and expressed in grams per deciliter (g/dL).
lactate(mmol/L)
Time frame: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)
Lactate, also known as lactic acid, is a molecule produced during the breakdown of glucose for energy, particularly when oxygen is limited. The common unit for lactate is millimoles per liter (mmol/L). In clinical tests, lactate concentration is usually expressed in this unit.
Dyspnea-12 score; D-12
Time frame: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)
D-12-C scale was developed, which demonstrated satisfactory reliability and validity in measuring dyspnoea among COPD patients.D-12 consists of 12 descriptor items on a scale of none (0), mild (1), moderate (2), or severe (3). Higher scores indicate more severe dyspnea.
Pulmonary function test-PEF (peak expiratory flow)(L/min)
Time frame: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)
Peak expiratory flow (PEF) or peak expiratory flow rate (PEFR) measures how quickly you can blow air out of your lungs. It's a way to assess how well your lungs are working, particularly for those with asthma or other lung conditions. A peak flow meter, a handheld device, is used to measure it.
lung function test- FEV1(Forced expiratory volume in the first second ) (L)
Time frame: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)
FEV1, or Forced Expiratory Volume in 1 second, is a measurement used in lung function tests, specifically spirometry. It represents the amount of air a person can forcefully exhale in the first second of a forced exhalation after taking a deep breath. The unit for FEV1 is liters (L)
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 5 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential Oil Diffusion Combined with Respiratory Training in people with Type 2 Diabetes Mellitus (T2DM) and Pulmonary Infections, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
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 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: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 Yu-Shan Hsieh (+886228227101, yushan@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting sugar (mg/dl) (time frame: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)). The study lists 8 primary outcomes in all. 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 5 Aug 2025.