Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma
Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma
The prevalence, low cost, and low burden of wearable devices that provide quantitative and
 qualitative feedback on a subject's activity level present an opportunity for the use of
 these devices in clinical and observational studies. However, the accuracy and
 reproducibility of any given device may vary with device design and algorithm implementation.
 Therefore, validation of emerging technologies against known standards such as analysis of
 exhaled breath and currently available medical devices is critical. This is a single center,
 two-cohort, single period, open-label, methodology study. No investigational product will be
 used in this study. Eligible subjects will wear 2 generations of SenseWear Armband devices, 2
 ActiGraph GT9x devices (one on the wrist and one on the waist) and a Garmin Vivofit 2
 activity tracker wristband for up to 24 hours per day. Subjects who consent to participate in
 an optional sub-study will wear a SOMNOwatch Plus EEG-6 device while sleeping. Subjects will
 perform a variety of laboratory and field-based exercise tests and strength exercises using
 Latex-Free Therabands.The co-primary objectives of this study are firstly to compare the
 outputs of the test devices (SenseWear Armband Gecko and Actigraph GT9x) to those of the
 SenseWear Armband MF and secondly to assess the sensitivity and accuracy of the test devices
 in subjects with COPD or asthma while performing laboratory-based exercise testing.
Inclusion Criteria:

 -  Cohort 1 (COPD) >=45 years and <=70 years

 -  Cohort 2 (Asthma) >=18 years and <=70 years.

 -  Cohort 1; subjects with a confirmed diagnosis of COPD (Gold stage 2 and 3, COPD
 patients will be classified according to Global Initiative for Chronic Obstructive
 Lung Disease [GOLD] Guidelines) as defined by post-bronchodilator spirometry FEV1
 >=40% and <80% predicted, and FEV1/FVC <0.7

 -  Cohort 2; subjects with documented, physician-diagnosed asthma.

 -  BMI within the range 19 to 32 kilogram(kg)/m^2 (inclusive)

 -  Male or female; A female of childbearing potential is eligible to enter and
 participate in the study if she has a negative pregnancy test at screening and day 1.

 -  Capable of giving written informed consent, which includes compliance with the
 requirements and restrictions listed in the consent form.

 Exclusion Criteria:

 -  Women who are pregnant or lactating or are planning on becoming pregnant during the
 study.

 -  Alpha1-antitrypsin deficiency: Subjects with a diagnosis of alpha1-antitrypsin
 deficiency as the underlying cause of COPD, if known.

 -  Other respiratory disorders: Subjects with tuberculosis, lung cancer, significant
 bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung
 diseases or other active pulmonary diseases.

 -  Pneumonia or other respiratory tract infection that has not resolved at least 14 days
 prior to screening. In addition, any subject that experiences pneumonia during any
 period between the screening visit and the study visit will be excluded.

 -  COPD or asthma exacerbation (in this case defined as a change in symptoms requiring
 increased doses of current medicines or the prescription of new medicines, e.g.,
 corticosteroids or antibiotics) that has not resolved at least 28 days prior to
 screening. COPD or asthma exacerbation during any period between the screening visit
 and the study visit will be excluded.

 -  Presence of severe and/or poorly controlled asthma that in the opinion of the
 investigator renders participation in the study unsafe

 -  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: orthopaedic, neurological, cardiovascular or other
 complaints that significantly impair normal biomechanical movement patterns and limit
 the ability to walk/cycle as judged by the investigator.

 -  Resting oxyhemoglobin saturation <94%.

 -  Use of supplemental oxygen therapy during the day or night.

 -  Drug/alcohol abuse: Subjects with a known or suspected history of alcohol (males >21
 units per week and females >14 units per week) or drug abuse within the last 2 years.
 One unit is equivalent to 8 gram (g) of alcohol: a half-pint (~240 milliliter [mL]) of
 beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.

 -  Inability to abstain from smoking during the period in which the subject is admitted
 to the Clinical Unit.

 -  A history of allergy or hypersensitivity to metal, particularly stainless steel.

 -  Clinically significant abnormality on electrocardiogram (ECG) as determined by the
 investigator.

 -  Any vital sign indicator, e.g., hypertension or tachycardia at rest that at the
 discretion of the investigator would make participation in the study unsafe or
 unfeasible.