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NCT Number: NCT07103460

Essential Oil-Assisted Respiratory Training in Type 2 Diabetic Patients With Lung Infections

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,

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Infections Lung Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pneumonia Pulmonary Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

I. Currently hospitalized due to pulmonary infection (ICD-10 codes: J00.x to J22.x).

II. 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.

V. Willing to participate in the study and consent to group assignment.

Exclusion criteria

I. Modified Rankin Scale (mRS) score ≥ 5, indicating severe functional impairment.

II. Diagnosed with dementia (unable to comprehend or follow intervention instructions).

III. 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.

VI. Diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency (ICD-10 codes: D55.x, D74-75.x).

Treatment and study plan

Essential Oil Diffusion Combined with Respiratory Training

Combination Product

three commonly used essential oils (wintergreen, peppermint, and eucalyptus) will be integrated into IS respiratory training

Primary outcomes

  1. 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.

  2. 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).

  3. 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%.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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)

Other outcomes

  1. Six-Minute walk test; 6MWT

    Time frame: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)

    The 6-minute walk test (6MWT) is a simple, submaximal exercise test used to assess a patient's functional exercise capacity. It measures how far a person can walk in six minutes on a flat, hard surface (meter).

Study contacts

Contact information is provided by the study sponsor or research team.

Yu-Shan Hsieh

CONTACT

[email protected]

+886228227101

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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