Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care
調査の概要
状態
詳細な説明
The proposed study is to gauge the early feasibility and acceptance of the SonoHeal device. The study will evaluate the usability of the SonoHeal prototype using well-established Human Factors Engineering methods recommended by the FDA. The investigators will also obtain preliminary comparison with the standard of care ACT device High Frequency Chest Wall Oscillation (HFCWO).
The study will be an iterative preliminary non-randomized pilot test to assess the translation of the SA1 RL algorithm from in-vitro models (3D lung and animal) to diseased human lungs. The subjects will use and provide feedback on the user interface and ease of operability of the prototype device. The software algorithm will be fine-tuned based on the clinical outcomes of the study. Participants have already had ≥2 ACT recent clinic sessions with the VEST device in the past 6 months to provide an estimate of the therapy outcomes, and the metrics will be compared against those obtained for the SonoHeal device. The primary outcomes will be qualitative; subjects will be interviewed and encouraged to verbalize their experience using the FDA-recommended Cognitive Walk-Through evaluation, and responses will be recorded for review and design improvements in the next stage. The quantitative outcome variables will be wet sputum weight and pre-post changes in resistance and FEV1 for preliminary comparison with the VEST for assessing algorithm performance. The sample size required is determined from the goal of identifying >90% of initial issues with the prototype device. Initially, N = 3 subjects in 3 sessions will be enrolled to evaluate and identify >90% of algorithmic, operational, and usability difficulties (problem discovery rate 70%, total n=9 sessions). Subsequently, N= 12 will be enrolled. The subjects will also undergo the personalization training session to optimize the algorithm parameters for each subject's unique response to airway clearance therapy.
Based on the results of Stage I experiments, the improved prototype device will be used for more extensive usability testing in the future.
研究の種類
入学 (推定)
連絡先と場所
研究場所
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California
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Santa Ana、California、アメリカ、92701-3515
- Ventura County Medical Center
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
The study population will be drawn from patients receiving routine clinical care for chronic airway diseases at Ventura County Medical Center and UCLA. This population includes adolescents and adults with established diagnoses of Cystic Fibrosis, Non-cystic fibrosis bronchiectasis, and Chronic Obstructive Pulmonary Disease who require ongoing airway clearance therapy (ACT) as part of standard disease management.
Patients in this population are typically managed in outpatient pulmonary or specialty clinics and have longitudinal follow-up within the health system. They commonly experience chronic sputum production and utilize daily ACT in combination with inhaled therapies such as bronchodilators and mucolytics. The population represents individuals with stable, chronic disease who are capable of performing routine airway clearance treatments in both clinical and home settings.
説明
Inclusion Criteria:
- Diagnosis of CF established by either genetic screening or positive chloride sweat test (Sweat chloride concentrations > 60mmol/L).
- Diagnosis of NCFB or COPD requiring regular use of airway clearance therapy.
- Age older than 11 years.
- History of chronic daily sputum production.
- Currently on a home therapeutic regimen that includes some form of ACT performed at least once daily that also includes concomitant use of an inhaled mucolytic and inhaled bronchodilator.
- Stage I eligibility for the 3 subjects will require patients who have had ≥2 ACT session with the VEST® in-clinic with lung function measured pre-post therapy.
- FVC and FEV1 > 35%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 2 months).
- Evaluated at the Ventura County Medical Center 2 or more times in the preceding 12 months.
- Signed informed consent given by the subject, or the parents, or a legally acceptable representative. If required by the Institutional Review Board/Ethics Committee (IRB/IEC), assent will be given by the subject.
- Ability to understand study requirements and comply with study procedures. Individuals of all ethnicities are included.
Exclusion Criteria:
- Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.
- Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.
- Chronic chest pain.
- Participation in another clinical trial in the previous 30 days.
- Use of intravenous antibiotics in the 2 months preceding enrollment.
- Inability or unwillingness of the participant to give written informed consent.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Observation Group
The study cohort consists of adolescent and adult patients (≥11 years of age) diagnosed with Cystic Fibrosis, Non-cystic fibrosis bronchiectasis, or Chronic Obstructive Pulmonary Disease who require ongoing airway clearance therapy (ACT) as part of their standard disease management. These individuals have a history of chronic daily sputum production and are maintained on a stable home regimen that includes routine ACT (at least once daily), along with concomitant use of inhaled mucolytics and bronchodilators. Participants are required to have relatively stable pulmonary status prior to enrollment, defined by lung function (FEV1 and FVC >35% predicted) without significant variation (>10%) over the preceding two months, and no recent pulmonary exacerbations. The study is observational at this stage to assess the feasibility and usability of the investigational SonoHeal device. |
The investigational intervention is the SonoHeal device, an adaptive airway clearance therapy (ACT) system designed to enhance mucus mobilization through individualized pressure/acoustic oscillations. The device utilizes the Forced Oscillation Technique (FOT) to continuously measure respiratory impedance, including airway resistance and reactance, during therapy. During each treatment session, patients use the SonoHeal device for a defined duration consistent with standard ACT practices. The device delivers high-frequency pressure oscillations intended to loosen and mobilize mucus within the airways, facilitating expectoration. Outcome measures associated with the intervention include changes in lung function parameters (e.g., resistance and reactance), sputum production during therapy, and overall treatment response. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Qualitative assessment
時間枠：Day 1: Baseline (pre-treatment), during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).
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The patients will describe their experience during the therapy using the Cognitive Walk Through Evaluation
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Day 1: Baseline (pre-treatment), during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).
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Time taken for training session
時間枠：Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).
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The time taken during the first training session will be measured.
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Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).
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Time taken for therapy duration
時間枠：Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).
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The time taken for therapy during each session will be recoded.
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Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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System Usability Questionnaire Assessment
時間枠：Day1 Post-treatment (within 1 hour).
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The subject will answer a 10-question system usability questionnaire to assess the ease of use of the system after each ACT session.
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Day1 Post-treatment (within 1 hour).
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Wet weight of sputum
時間枠：Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).
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The wet weight of sputum expectorated by the subject during and post ACT.
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Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).
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Spirometry
時間枠：Day 1: Baseline (pre-treatment), and 20 minutes post-treatment
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Spirometry parameters of FEV1, PEF, FVC, FEV6.
The nurse or respiratory therapist will conduct the spirometry test.
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Day 1: Baseline (pre-treatment), and 20 minutes post-treatment
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Airway impedance
時間枠：Day 1: Baseline (pre-treatment), and 20 minutes post-treatment
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Airway impedance parameters as measured by Forced Oscillation Technique:
The nurse or respiratory therapist will conduct the FOT test. |
Day 1: Baseline (pre-treatment), and 20 minutes post-treatment
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Chris Landon, M.D.、Ventura County Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- SonoHeal
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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