The effect of cognitive illusion of airway flow on multidimensional breathlessness during inspiratory resistive breathing in patients with Interstitial lung disease

JRCT ID: jRCT1030220389

Registered date:18/10/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: interstitial lung disease
• Date of first enrollment: 01/11/2022
• Target sample size: 40
• Study type: Interventional
• Intervention(s): The intervention is a menthol-scented Toka Sangyo Co. aroma patch applied to a face mask. The placebo is a strawberry-scented aroma patch applied to a face mask. An inspiratory resistance tube will be connected to the inspiratory port at the end of the mask, and participants will perform tidal breathing under a menthol-scented aroma for 2 minutes under inspiratory resistance-loaded breathing conditions; after a 20-minute break, participants will perform tidal breathing under strawberry-scented aroma for placebo under inspiratory resistance-loaded conditions. Participants will perform resting ventilation under baseline inspiratory resistive load for 2 minutes, followed by random menthol and placebo scent conditions. Rest periods for the placebo and menthol scent conditions will be 20 minutes. Thus, the menthol scent condition and the placebo condition will be performed once for 2 minutes each.

Outcome(s)

• Primary Outcome: Japanese version of mulditimensional dyspnea profile
• Secondary Outcome: Inspiratory flow perception, transcutaneous arterial partial pressure of oxygen

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: The study included 40 outpatients with interstitial lung disease who had not had an exacerbation within 4 weeks.
• Exclude criteria: Subjects who may be offended by odours or perfumes are excluded. Exclude congestive heart failure, acute coronary artery disease, olfactory disorders, neuromuscular disorders, severe psychiatric disorders, neuromuscular diseases, serious psychiatric disorders and patients undergoing treatment with sedatives.

Related Information

• Primary Sponsor: Terada Kunihiko