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N/A N=27

Feasibility Study to Use Biosensing Devices to Monitor PA and Resp. Function in Smokers w and w/o Resp. Symptoms/COPD

Signs and Symptoms, Respiratory · Mobile Applications · Activity Trackers · Respiratory Function Tests

Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Rate of Recruitment — 9; 9; 9 Participants

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Anamed OEM device; Air Next mobile spirometry device (Device)
Age
Adult · 40+ yrs
Sex
All
Sponsor
Kazakhstan Academy of Preventive Medicine
Primary completion
Oct 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Rate of Recruitment
9; 9; 9
PRIMARY
Rate of Retention
9; 9; 9
PRIMARY
Protocol Adherence
4; 5; 8

Summary

This study examines the feasibility and acceptability of using mobile applications and biosensing (mHealth) devices in detecting vitality parameters in current smokers with and without respiratory symptoms/COPD (e.g., heart rate, blood oxygenation, steps/motion) for a future big-scale study.

Eligibility Criteria

Inclusion Criteria

  • Current smokers who are currently smoking conventional cigarettes with a minimum of 10 pack-year smoking history
  • Able to use and willing to be trained to use mHealth devices

Exclusion Criteria

  • COPD exacerbation that has not resolved at least 28 days prior to screening
  • COPD exacerbation occurring after screening but before the first study visit
  • Pneumonia or other respiratory tract infections that have not resolved at least 14 days prior to screening
  • Pneumonia occurring after screening but before the first study visit
  • Active respiratory disorders: tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, bronchial asthma, lung fibrosis, pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases
  • Any co-morbid medical condition that in the opinion of the investigator would make participation in the study unsafe or unfeasible, including conditions that prohibit completion of exercise testing
  • Use of supplemental oxygen therapy
  • Inability to abstain from smoking during the period in which the participant is admitted to the Kazakhstan Academy of Preventive Medicine (KAPM) COPD Center
  • A history of allergy or hypersensitivity to metal, particularly stainless steel
  • Any vital sign indicator, for example, hypertension or tachycardia at rest that, at the discretion of the investigator, would make participation in the study unsafe or unfeasible
  • Women who test positive for pregnancy during screening, lactating women, or women planning on becoming pregnant during the study
  • Participants using assistive devices like walking aids, as these are likely to interfere with physical activity
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04081961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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