Last updated: 11/03/2018 22:22:54
Method validation study to explore the sensitivity of SenseWear Armband Gecko for measuring physical activity in subjects with chronic obstructive pulmonary disease (COPD) & Asthma
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Energy expenditure [kilocalories per minute]
Timeframe: Up to Day 2
Energy expenditure [metabolic equivalents]
Timeframe: Up to Day 2
Step counts [total number of steps taken]
Timeframe: Up to Day 2
Secondary outcomes:
Number of subjects with adverse events (AE) or serious adverse events (SAE).
Timeframe: From the start of Study procedures until follow-up (6 days)
Number of subjects with abnormal vital signs related to interventions.
Timeframe: Screening and Days 1 and 2
Forced Expiratory Volume in 1 second (FEV1)
Timeframe: Screening
Ratio of FEV1 and Forced Vital Capacity (FVC)
Timeframe: Screening
Borg dyspnea index score
Timeframe: Days 1 and 2
Interventions:
Device: SenseWear Armband Gecko
Device: SenseWear Armband MF
Device: Actigraph GT9x wristband and waistband
Device: Garmin Vivofit 2 wristband
Device: SOMNOwatch plus EEG 6 sleep monitor
Other: Strength exercises
Other: Field-based exercise tests
Other: Laboratory-based exercise tests
Enrollment:
22
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
September 2015 to March 2016
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 70 years
Accepts healthy volunteers
No
- Cohort 1 (COPD) >=45 years and <=70 years
- Cohort 2 (Asthma) >=18 years and <=70 years.
- 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.
Inclusion and exclusion criteria
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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2016-16-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 202373 can be found on the GSK Clinical Study Register.
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