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Japanese

Mar. 05, 2021

May. 25, 2023

jRCTs031200400

Effects of olfactory stimulation by L-menthol on dyspnea on exertion in chronic lung disease: A pilot study

Effects of olfactory stimulation by L-menthol on dyspnea on exertion in chronic lung disease: A pilot study

Sakao Seiichiro

Chiba University Hospital

1-8-1 Inohana Chuo-ku, Chiba-shi

+81-43-222-7171

sakaos@faculty.chiba-u.jp

Inagaki Takeshi

Chiba Prefectual University of Health Sciences

645-1, Nitona, Chuo-ku, Chiba-shi

+81-43-305-2184

takeshi.inagaki_19@cpuhs.ac.jp

Complete

Mar. 05, 2021

April. 14, 2021
34

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

1) Patients with COPD or IIPs who are attending a respiratory medicine in our hosuital
2) Patients who are 20 years of age or older at the time of obtaining consent
3) Patients who are able to walk independently
4) Patients who can accurately perform respiratory function tests and 6MWT
5) Patients whose condition is stable and who have not changed their treatment for more than three months
6) Patients who have been fully informed of the contents of this study and have given written consent
7) Patients who are in or have completed an outpatient rehabilitation program, have stable symptoms, and are not scheduled for an outpatient rehabilitation program during this study

1) Patients with severe orthopedic or central nervous system disease who need assistance with daily living
2) Patients who have been hospitalized for an exacerbation of an primary disease within the past six months
3) Patients with unstable cardiac disease
4) Patients with a history of other serious lung diseases such as occupational lung, sarcoidosis, airway hypersensitivity, malignant diseases, or lung infections caused by immunodeficiency
5) Patients with nasal obstruction and olfactory disturbances
6) Patients who are judged by the principal investigator/assistant physician to have a risk of compromising patient safety or to have difficulty complying with the protocol

20age old over
No limit

Both

Chronic obstructive pulmonary disease, Idiopathic interstitial pneumonias

Aroma seals coated with L-menthol are applied to a surgical mask and the mask is worn for a walking test.

chronic respiratory failure

L-menthol

modified Borg Scale before and after 6-minute walking test

SpO2 (before and after 6MWT)
Pulse rate (before and after 6MWT)
6 minute walking distance
St. George`s Respiratory Questionnaire (SGRQ)
Steps/day
Nagasaki University Respiratory ADL Questionnaire (NRADL)
Quadriceps force
Grip force
Respiratory muscle force (PImax/PEmax)
pulmonary function
Dyspnea Language Questionnaire
Multidimensional Dyspnea Profile
Adverse event

Chiba University Hospital
Not applicable
Certified clinical research review board , Chiba University
1-8-1 Inohana Chuo-ku, Chiba-shi, Chiba

+81-43-226-2616

prc-jim@chiba-u.jp
Approval

Feb. 03, 2021

none

History of Changes

No Publication date
9 May. 25, 2023 (this page) Changes
8 May. 25, 2023 Detail Changes
7 Jan. 24, 2023 Detail Changes
6 Jan. 23, 2023 Detail Changes
5 May. 24, 2022 Detail Changes
4 April. 08, 2022 Detail Changes
3 Sept. 02, 2021 Detail Changes
2 May. 28, 2021 Detail Changes
1 Mar. 05, 2021 Detail