Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Method Validation, Single-period, Open-label Evaluation Study to Explore the Sensitivity of a Novel Biosensor Device (SenseWear Armband Gecko) for Measuring Physical Activity in Subjects With COPD & Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02619357
• Other study ID #: 202373
• Status: Completed
• Phase: Phase 1
• First received: August 27, 2015
• Last updated: May 12, 2017
• Start date: September 21, 2015
• Est. completion date: March 16, 2016

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 16, 2016
• Est. primary completion date: March 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• SenseWear Armband Gecko
Subjects will wear SenseWear Armband Gecko up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests
• SenseWear Armband MF
Subjects will wear SenseWear Armband MF up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests
• Actigraph GT9x wristband and waistband
Subjects will wear Actigraph GT9x wristband and waistband up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests
• Garmin Vivofit 2 wristband
Subjects will wear Garmin Vivofit 2 wristband up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests
• SOMNOwatch plus EEG 6 sleep monitor
In a subset of subjects, this device will be worn as a comparator for monitoring sleep quality and duration.

Other:
• Strength exercises
Subjects will perform strength exercises using elastic bands of varying resistance
• Field-based exercise tests
Subjects will perform an Incremental Shuttle Walk Test (ISWT) and each individual component of a Short Physical Performance Battery (SPPB).
• Laboratory-based exercise tests
Subjects will perform an incremental, symptom-limited cardiopulmonary exercise test on a cycle ergometer and will walk at various speeds on a treadmill

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy expenditure [kilocalories per minute]	Energy expenditure will be assessed by test devices at various levels of exertion during field-based and laboratory-based exercise tests. Graphical and/or statistical comparisons will be made between test devices and with information derived from indirect calorimetry obtained by exhaled gas analysis, where available.	Up to Day 2
Primary	Energy expenditure [metabolic equivalents]	Energy expenditure will be assessed by test devices at various levels of exertion during field-based and laboratory-based exercise tests. Graphical and/or statistical comparisons will be made between test devices and with information derived from indirect calorimetry obtained by exhaled gas analysis, where available.	Up to Day 2
Primary	Step counts [total number of steps taken]	Step counts will be collected by test devices at various levels of exertion during field-based and laboratory-based exercise tests. Graphical and/or statistical comparisons will be made between devices and with manually counted steps, where available.	Up to Day 2
Secondary	Number of subjects with adverse events (AE) or serious adverse events (SAE).	AEs and SAEs will be collected for each subject from the start of study until the follow-up contact	From the start of Study procedures until follow-up (6 days)
Secondary	Number of subjects with abnormal vital signs related to interventions.	Oral temperature (degrees Celsius), systolic and diastolic blood pressure (mmHg), heart rate (beats per minute), respiratory rate (breaths per minute), and oxygen saturation (percent) will be collected at various times throughout the study.	Screening and Days 1 and 2
Secondary	Forced Expiratory Volume in 1 second (FEV1)	Post-salbutamol spirometry will be obtained at screening, if necessary. Post- salbutamol FEV1 will be determined.	Screening
Secondary	Ratio of FEV1 and Forced Vital Capacity (FVC)	Ratio of FEV1 and Forced Vital Capacity (FVC) will be determined at screening.	Screening
Secondary	Borg dyspnea index score	Borg dyspnea scores will be obtained during and after exercise.	Days 1 and 2

External Links

•   Results for study 202373 can be found on the GSK Clinical Study Register.