Assessment of a Standardized Home Spirometry Method for Frequent Monitoring of Lung Function in a Normal Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Feasibility of using the Standardized Home Spirometry (SHS) Method and associated IT Dashboard Server: Assess Home Spirometry reproducibility during pre-surveillance period.
研究概览
简要总结
This study was designed to evaluate the feasibility of using a Standardized Home Spirometry (SHS) Method to develop normal range values, to detect a variance (i.e., a value outside of that normal range), to evaluate a variance with a questionnaire, and to download all data in normal volunteers prior to evaluation and use on a larger scale for lung transplant recipients. The Standardized Home Spirometry (SHS) Method consists of a FDA-approved Bluetooth Spirometry unit, FDA approved Bluetooth Pulse Oximeter and an Android-based Tablet which is embedded with an investigational Home Spirometry Mobile Medical Software Application for data and symptom survey collection and transmission over secure WiFi or cellular connectivity in HIPAA compliant fashion (labeled only with a date/time and machine ID stamp) to an associated investigational IT Server Dashboard at the Central Monitoring Institute Server at Washington University in St. Louis.
详细描述
Study Objective: This study was designed to evaluate the feasibility of use of a Standardized Home Spirometry(SHS) Method using a Home Spirometry Monitoring Kit consisting of FDA-approved Blue-tooth Spirometry unit, Blue-tooth pulse oximeter and an Android-based Tablet with an embedded investigational home spirometry mobile medical software application for data and symptom survey collection and transmission over secure WiFi or cellular data transmission portal in HIPAA compliant fashion to an associated investigational IT dashboard application at the Central Monitoring Institute (CMI) Server at Washington University in St. Louis, to develop normal range values, to detect a variance (i.e., a value outside of that normal range), to evaluate a variance with a questionnaire, and to download all data to the CMI in a small pilot of healthy volunteers prior to evaluation and use on a larger scale for lung transplant recipients.
The investigational IT application will monitor lung function but do nothing more than collect data. It will adjust monitoring frequency and trigger physician review of home spirometry results at a more frequent interval but will not be directly involved in decisions regarding diagnosis or treatment.
Study Type: Non-randomized, single-arm, prospective cohort study
Intervention:
- The Home Spirometry Monitoring System will consist of:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age (18 years old or older)
- •Volunteers who provide written informed consent to participate in this study and who are willing and able to perform frequent home spirometry monitoring and laboratory-based spirometry if practicable, per protocol.
排除标准
- •Known cardiac, pulmonary or other condition, that may interfere with the subject's ability to perform lab-based pulmonary function testing or standardized home spirometry.
- •Any condition that would significantly affect the participant's ability to adhere to the protocol, or affect interpretation of the study results.
- •Pregnant or planning to become pregnant during the study. Pregnant volunteers are excluded as changes in spirometry associated with a gravid uterus could alter outcome data. (Volunteers should take measures to prevent pregnancy while participating in the study.)
- •Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance, lack of WiFi and/or cellular access or inadequate English literacy/comprehension to operate the Home Spirometry System)
- •Concomitant participation in another trial with an investigational device or investigational drug
研究组 & 干预措施
Standardized Home Spirometry (SHS) Method
The Standardized Home Spirometry (SHS) Method consists of an Investigational Mobile Medical Application embedded in an Android Tablet & FDA approved spirometer & pulse oximeter.
Participants will be trained with the SHS method, perform an initial home spirometry test session & a lab-based spirometry test (if practicable).
Pre-surveillance Phase:Daily SHS Testing for 4 to 10 weeks to enable the Mobile Medical application to generate volunteer specific normal range.
Surveillance Phase: At least weekly SHS Testing. During approximately two months of the surveillance phase, the volunteer will test one to four times per week to assess the SHS neural pathways as directed by the study team. Test sessions will be documented on a test log. Subjects may be asked to perform additional SHS pathway test logs, continue at least weekly testing, pause testing or end participation following completion of the initial SHS neural pathway test log.
干预措施: Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeter (Device)
结局指标
主要结局
Feasibility of using the Standardized Home Spirometry (SHS) Method and associated IT Dashboard Server: Assess Home Spirometry reproducibility during pre-surveillance period.
时间窗: Up to 8 weeks
Evaluate daily FEV1 variability between replicate measurements by summarizing between measurement %difference; Evaluate between day variability in highest FEV1 (FEV1 Max) variability by summarizing %Difference from FEV1 Max values and two SD (Standard Deviation) Coefficient of Variation (expected to be less than 30%) between FEV1 measurements during pre-surveillance period.
Feasibility of using the Standardized Home Spirometry (SHS) Method and associated IT Dashboard Server: Pathway Verification
时间窗: Through study completion, up to 10 months
Evaluate the Mobile medical application software and associated IT server data processing pathways using % initial error rate (initial error rate and subsequent error rate, after any potential adjustments are made in mobile medical application if changes are required).
Feasibility of using the Standardized Home Spirometry (SHS) Method and associated IT Dashboard Server: Drift Assessment
时间窗: Up to 8 weeks
Evaluate the functionality of the investigational Mobile Medical Software Application and associated IT Server Dashboard for statistically significant drift in relationship between %FEV1 Max or mean FEV1 Max over time and subsequent transition to Surveillance monitoring stage.
次要结局
未报告次要终点