Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk (TELESAS)
調査の概要
詳細な説明
The obstructive sleep apnea syndrome (OSAS) corresponds to repeated epochs of complete or incomplete pharynx collapses occurring during sleep. The Continuous Positive Airway Pressure is the gold standard treatment for OSAS. It consists of air insufflation in upper airways with a pressure of about 5 to 15 cm of water with a facial or nasal mask. CPAP treatment reduces cardiovascular morbi-mortality.
OSAS is associated with cardiovascular mortality. A dose response effect exists between severity and arterial blood pressure. A recent meta-analysis has shown in unselected OSAS patients with or without hypertension, treated or non-treated for hypertension, CPAP reduces 24 h ambulatory blood pressure of approximately 2 mmHg. This decrease corresponds to a significant reduction in cardiovascular risk.
The aim of the present study is to include OSAS patients with a high cardiovascular risk and to measure the effect of CPAP on home measurements of arterial blood pressure. This controlled randomized trial will compare the effect CPAP on arterial blood pressure in a group with a telemedicine system versus a group with standard home care CPAP treatment.
An interim analysis will be carried out when 100 patients have been included in the study.
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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Boulogne Billancourt、フランス、92100
- Liberal Office
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Brest、フランス、29200
- Clermont Tonerre military hospital
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Chambery、フランス、73000
- Liberal Office
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Grenoble、フランス、38000
- University Hospital
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Grenoble、フランス、38000
- Liberal Office
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Montigny les Metz、フランス、57950
- Liberal Office
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Nancy、フランス、54000
- Liberal Office
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Quimper、フランス、29107
- Cornouaille Hospital
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St Andre les Vergers、フランス、10120
- Montier Polyclinic
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St Avold、フランス、57500
- Hospitalor Hospital
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St Jean de Maurienne、フランス、73300
- Liberal Office
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St Martin les Boulogne、フランス、62280
- Liberal Office
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StIsmier、フランス、38330
- Liberal Office
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Strasbourg、フランス、67000
- Liberal Office
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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:
- 18 to 85 years old men and women
- stable patient
- BMI<40kg/m²
- OSA patients diagnosed with polysomnography or polygraphy
- SCORE>5% and/or cardiovascular disease pas history :
- transient ischemic attack, stroke, cerebral haemorrhagy
- myocardial infraction, angor, coronary revascularization, arteriopathy, aortic aneurism
Exclusion Criteria:
- central sleep apnea syndrome
- SCORE<5%
- cardiac failure
- past history of hypercapnic chronic respiratory failure
- past history of severe or intercurrent pathology which can not allow the patient follow-up
- Incapacitated patients in accordance with article L 1121-6 of the public health code
- patients taking part in another clinical trial
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Telemedecine
CPAP treatment with telemedicine system
|
CPAP treatment with telemedicine system
|
|
アクティブコンパレータ：Standard Care
Standard care, including CPAP
|
Standard care, including CPAP
|
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 |
|---|---|---|
|
Home Arterial Blood Pressure
時間枠：Home arterial Blood Pressure is assessed at week 1
|
the primary outcome is assessed at weeks 1 and 16 for the both groups, moreover home arterial blood pressure is assessed each day, 2 times : morning and afternoon in the telemedicine group.
|
Home arterial Blood Pressure is assessed at week 1
|
|
Home Arterial Blood Pressure
時間枠：Home arterial Blood Pressure is assessed at week 16
|
the primary outcome is assessed at weeks 1 and 16 for the both groups, moreover home arterial blood pressure is assessed each day, 2 times : morning and afternoon in the telemedicine group.
|
Home arterial Blood Pressure is assessed at week 16
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
CPAP compliance
時間枠：week 16
|
the CPAP compliance is assessed in the two groups at week 16
|
week 16
|
|
Sleepiness
時間枠：weeks 1 and 16
|
Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups
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weeks 1 and 16
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Physical Activity
時間枠：week 1
|
Daily Physical Activity is assessed with an accelerometer (Sensewear Armband, Bodymedia) at weeks 1 and 16 in the two groups.
Daily expenditure, steps number, daily METs are assessed.
|
week 1
|
|
Quality of Life
時間枠：week 16
|
Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups.
|
week 16
|
|
Cardiovascular risk SCORE
時間枠：Week 1
|
The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups.
|
Week 1
|
|
Sleepiness
時間枠：week 16
|
Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups
|
week 16
|
|
Physical Activity
時間枠：week 16
|
Daily Physical Activity is assessed with an accelerometer (Sensewear Armband, Bodymedia) at weeks 1 and 16 in the two groups.
Daily expenditure, steps number, daily METs are assessed.
|
week 16
|
|
Quality of Life
時間枠：week 1
|
Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups.
|
week 1
|
|
Cardiovascular risk SCORE
時間枠：Week 16
|
The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups.
|
Week 16
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Jean Louis PEPIN, Prof, PhD、University Hospital, Grenoble
出版物と役立つリンク
一般刊行物
- Mendelson M, Vivodtzev I, Tamisier R, Laplaud D, Dias-Domingos S, Baguet JP, Moreau L, Koltes C, Chavez L, De Lamberterie G, Herengt F, Levy P, Flore P, Pepin JL. CPAP treatment supported by telemedicine does not improve blood pressure in high cardiovascular risk OSA patients: a randomized, controlled trial. Sleep. 2014 Nov 1;37(11):1863-70. doi: 10.5665/sleep.4186.
- Mendelson M, Tamisier R, Laplaud D, Dias-Domingos S, Baguet JP, Moreau L, Koltes C, Chavez L, de Lamberterie G, Herengt F, Levy P, Flore P, Pepin JL. Low physical activity is a determinant for elevated blood pressure in high cardiovascular risk obstructive sleep apnea. Respir Care. 2014 Aug;59(8):1218-27. doi: 10.4187/respcare.02948.
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 (見積もり)
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
- InitiativePS-TELESAS
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