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

May 12, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB2 2GG
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1
10 subjects diagnosed with COPD (GOLD stages 2 and 3). Subjects will wear multiple devices simultaneously (SenseWear Armband Gecko, SenseWear Armband MF, Actigraph GT9x wristband and waistband and 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.
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
Device: 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
Device: 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
Device: 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
Device: 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
Other: Field-based exercise tests
Subjects will perform an Incremental Shuttle Walk Test (ISWT) and each individual component of a Short Physical Performance Battery (SPPB).
Other: 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
Experimental: Cohort 2
10 subjects diagnosed with asthma. Subjects will wear multiple devices simultaneously (SenseWear Armband Gecko, SenseWear Armband MF, Actigraph GT9x wristband and waistband and 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.
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
Device: 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
Device: 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
Device: 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
Device: 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
Other: Field-based exercise tests
Subjects will perform an Incremental Shuttle Walk Test (ISWT) and each individual component of a Short Physical Performance Battery (SPPB).
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Energy expenditure [kilocalories per minute]
Time Frame: Up to Day 2
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
Energy expenditure [metabolic equivalents]
Time Frame: Up to Day 2
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
Step counts [total number of steps taken]
Time Frame: Up to Day 2
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of subjects with adverse events (AE) or serious adverse events (SAE).
Time Frame: From the start of Study procedures until follow-up (6 days)
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)
Number of subjects with abnormal vital signs related to interventions.
Time Frame: Screening and Days 1 and 2
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
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: Screening
Post-salbutamol spirometry will be obtained at screening, if necessary. Post- salbutamol FEV1 will be determined.
Screening
Ratio of FEV1 and Forced Vital Capacity (FVC)
Time Frame: Screening
Ratio of FEV1 and Forced Vital Capacity (FVC) will be determined at screening.
Screening
Borg dyspnea index score
Time Frame: Days 1 and 2
Borg dyspnea scores will be obtained during and after exercise.
Days 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 16, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202373

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