Evaluation of a smartphone application that analyzes sensory changes and autonomic responses in chronic pain sufferers induced by short term lowering barometric pressure

UMIN ID: UMIN000052352

Registered date:05/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: weather-related pain
• Date of first enrollment: 2023/10/05
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Subjects are exposed to a low-pressure environment (atmospheric pressure -40hPa; 30min.) that simulates weather disturbances. A smartphone application will then accurately detect changes in pain and changes in autonomic activity induced by lowering barometric pressure, and confirm that when pain intensifies, stress levels simultaneously increase.

Outcome(s)

• Primary Outcome: Changes in pain score (Numeric Rating Scale) induced by low-pressure exposure
• Secondary Outcome: 1) Pulse and pulse wave interval fluctuations 2) Artificial weather data (barometric pressure, temperature, humidity)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 59years-old
• Gender: Male and Female
• Exclude criteria: Persons who violate any of the following will not be included in this survey. 1) Aichi Medical University student 2) Those who are pregnant or breastfeeding 3) Persons suffering from diseases that must be excluded from research subjects. Diseases not targeted for this research are defined as a secondary headache that does not meet the diagnostic criteria for primary headaches (migraine, tension-type headache, or both) and is caused by another disease or condition. 4) Others (under medication, treatment, etc.) who are deemed unsuitable as participants by the principal investigator and co-investigators.

Related Information

• Primary Sponsor: Aichi Medical University
• Source(s) of Monetary Support: Pascal Universe Co. Ltd.