Mixed Methods Evaluation of a Novel Apnoea Event Detection Monitor
A Mixed-methods Evaluation of a Novel Apnoea Event Detection Monitor in Comparison to Standard of Care Limited Overnight Polysomnography
This investigation is looking at a currently available technology to see if it could have another use i.e. in helping to diagnose patients with sleep apnoea.
With 2-4% of the population suffering from this disease, and the current wait time for a test at approximately 20 weeks, it is hoped that a simple screening method could help speed up the process of finding these patients and getting them on treatment faster.
The current standard of care test involves a sleep study in the patients own home with a device with multiple parts and wires. The RespiraSense Sleep Screener is completely cableless and consists of one small, discrete unit attached to the patients side and a mobile device plugged in by the bed.
Patients at Queen Alexandra Hospital who are prescribed sleep studies will be invited to participate. The RespiraSense Sleep Screener data is only for comparison purposes and will have no effect on their clinical care.
If patients agree to participate they will undergo the sleep study with both devices in the same night and may be followed up with over the phone on their experiences with the test.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Portsmouth、イギリス、PO6 3LY
- Queen Alexandra Hospital
-
-
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients ≥ 18 Years
- Patients due to undergo home monitoring to investigate presence of sleep apnoeic events
- Patients able to provide informed consent to participate in this investigation
Exclusion Criteria:
- Patients with known respiratory disorders that are uncontrolled at the time of the sleep study
- Patients allergic to medical grade skin adhesive
- Patients on long term, oral steroid use
- Pregnant women during second and third trimester
- Patients presently on any sleep disorder therapy
- Patients with any history of substance abuse (drug or alcohol) that may interfere with their ability to cooperate and comply with the investigation procedures
- Patients with any disorder, including cognitive dysfunction, which would affect the ability to accurately complete questionnaires and freely give full 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
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 |
|---|---|---|
|
Similarity to standard of care
時間枠：One night
|
The mean error of the device relative to the overnight polysomnography tests ≥ 10 AHI
|
One night
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Qualitative evaluation of RespiraSense
時間枠：One night
|
to qualitatively evaluate the perceptions, values and opinions of the RS Sleep Screener device compared with the comparator to identify potential modifications to improve patient acceptance and to inform future implementation of the device within the NHS setting
|
One night
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Anoop Chauhan、Portsmouth Hospitals NHS Trust
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
その他の研究ID番号
- PMD-CS-008
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
RespiraSense Sleep Screenerの臨床試験
-
Leiden UniversityBioClock Consortium; Caring Univeristies完了
-
University of Texas at Austin完了