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
Bottom Line
View on ClinicalTrials.gov: NCT04081961 ↗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
| Outcome | Result | p-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
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.