Remote Monitoring in Obstructive Sleep Apnea
Remote Monitoring in Obstructive Sleep Apnea Management in Military Veterans
調査の概要
状態
条件
詳細な説明
Prior to enrollment, patients were seen by a clinician at the Veterans Administration (VA) Hospital in West Haven, Connecticut. Either a facility-based diagnostic polysomnogram or unattended home sleep testing was performed at the evaluating clinician's discretion. Clinicians that saw the patient determined whether PAP therapy was needed, and either auto-titrating continuous positive airway pressure (CPAP) or set pressures of CPAP were ordered for the patient. Patients received education about OSA and about their equipment from a respiratory therapist and physician's assistant within the VA who then provided the equipment for them. Patients coming to this internal Durable Medical Equipment (DME) provider were screened for participation in the study.The study was overseen by the Institutional Review Board at the Veterans Affairs Connecticut Health Care in West Haven, Connecticut. Informed consent was obtained from all participants.
Patients were included in the study if they were diagnosed with OSA (defined as AHI or apnea-hypopnea index greater than five per hour with symptoms, or AHI greater than 15/hour), and if they were being exposed to PAP for the first time. Patients who were previously treated with PAP, had central apnea, chronic respiratory failure, recent in-patient hospital admissions (=< 2 weeks), or were living outside cellular network coverage area were excluded from the study.
Patients that met study inclusion criteria were provided ResMed S9 devices with wireless modems. Their usage and treatment data was tracked using EasyCare Online, a cloud-based system for the ResMed devices. After the initial setup and educational settings, the patients received supplies as needed and troubleshooting of side effects of treatment as needed. Devices were not removed after 3 months if they were not adherent.
Patients in the usual care group were monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits. Adherence and efficacy data were only assessed by the clinician at these intervals.
Patients in the wireless care group were monitored more frequently using wireless modems as the method to obtain adherence and efficacy data.
We then determined adherence using CMS (Centers for Medicare & Medicaid Services) criteria at 3 months, and at 12 months. To obtain this data, we evaluated whether the PAP devices were used for 4 or more hours per night on 70% of nights during a consecutive 30-day period anytime during the first 3 months of initial use, and then a consecutive 30-day period in months 4-12. We also examined the daily use from the first to last day looking of overall patterns of utilization monthly, quarterly, semiannually and annually. Data was collected and maintained in a REDCap database (REDCap is a secure web application for building and managing online surveys and databases). Sensitivity and specificity calculations were then performed to evaluate predictability of adherence at 1 year using adherence at 3 months. Fisher's exact test was also used to evaluate the association between adherence at 3 months and 1 year and the association between AHI (Apnea -Hypopnea Index) and adherence.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Connecticut
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West Haven、Connecticut、アメリカ、06516
- VA Connecticut Health System
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Newly diagnosed OSA patients
- AHI of 5/hour or greater
- Prescribed CPAP therapy
- Able to comply with treatment and understand treatment instructions
Exclusion Criteria:
- Not able to understand study requirements
- Significant cardiorespiratory disease - e.g. COPD (chronic obstructive pulmonary disease), severe CHF (congestive heart failure)
- Clinical instability at time of apnea diagnosis
- Prescribed BiPap (bilevel positive airway pressure) or ASV (Adaptive Support Ventilation), which are other types of PAP
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
- 主な目的:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ:Usual Care
Monitoring every 3 months by face-to-face visits:These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits.
Adherence and efficacy data will only be assessed by the clinician at these intervals.
|
These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits.
Adherence and efficacy data will only be assessed by the clinician at these intervals.
|
アクティブコンパレータ:Wireless Care
Frequent remote monitoring:These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.
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These patients will be monitored using wireless modems as the method to obtain adherence and efficacy and follow-up phone calls
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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 |
---|---|---|
Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months
時間枠:First 3 months
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Positive Airway Pressure Treatment Adherence defined as mean PAP use being > 4 hours per night for greater than 70% of nights.
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First 3 months
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Number of Participants With Positive Airway Pressure Treatment Adherence After 3 Months
時間枠:4-12 Months
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Demonstrated Periodic Adherence After 3 Months of Treatment During 4-12 months defined as mean PAP use being > 4 hours per night for greater than 70% of nights
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4-12 Months
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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 |
---|---|---|
Receiving Effective Treatment for Obstructive Sleep Apnea
時間枠:12 months
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Evaluate whether patients are effectively being treated with PAP or with alternate means of treatment for OSA (obstructive sleep apnea) at the end of 12 months.
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12 months
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協力者と研究者
捜査官
- 主任研究者:Meir Kryger, MD、VA Connecticut Healthcare System
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
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閉塞性睡眠時無呼吸の臨床試験
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University Hospital, Bonnわからない合併症 | 睡眠時無呼吸 (Apnea Hypopnea Index > 5/h として定義) | 頭蓋内動脈瘤のサイズ | 血圧の薬 | 合併症(くも膜下出血)ドイツ