Follow-up of Patients With Obstructive Sleep Apnea in Primary Care.
Follow-up of Patients With the Apnea-hypopnea Syndrome in Primary Care and Sleep Disorders Units. Equivalence Randomized Comparative Study on Compliance and Clinical Response.
The objective of the study is to compare the results of a coordinated and interactive program for the treatment, monitoring and control of patients with a moderate-severe diagnosis of Obstructive Sleep Apnea (OSA) and treated with positive continuous pressure (CPAP), with the currently established situation.
Methodology: Equivalence randomized comparative study . It will include patients with diagnosis of moderate-severe OSA (apnea-hypopnea Index >=15) that should start treatment with (CPAP). Participating center is Hospital Santa María-Arnau de Vilanova in Lleida (Spain).These patients will be randomized to two monitoring groups (1: monitoring in the Sleep disorders unit, 2: monitoring in primary care consultations) once the OSAS diagnosis has been made and it was indicated that treatment with CPAP. Patients Will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 months and 6 months. Primary outcomes: number of hours of use per day (according to the accountant of the CPAP), so that use >= 4h/day is defined as good adherence to the treatment. Secondary outcomes: daytime sleepiness, patient satisfaction, Adverse events related to CPAP treatment. It will be collected demographic ,clinics and anthropometric variables. At the end of follow-up primary and secondary outcomes will be compared between two groups.
調査の概要
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
-
-
Catalonia
-
Lleida、Catalonia、スペイン、25198
- Hospital Santa Maria
-
-
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:
- Men and women over 18 years old.
- Patients with OSA diagnosis performed in the sleep units
- Written informed consent signed.
Exclusion Criteria:
- Previous CPAP treatment for OSA diagnosis
- Psycho-physical inability to complete questionnaires.
- Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, regular use of hypnotic or sedative medications and restless leg syndrome
- Patients with respiratory diseases (overlap syndrome, hypoventilation, restrictive diseases)
- A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions.
- Any medical factor, social or geographical, that may jeopardize patient compliance.(e.g., alcohol consumption (more 80 gr/day in men and more than 60 gr / day in women), no fixed address, disorientation, or a history of non-compliance).
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：支持療法
- 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 |
|---|---|
|
介入なし：Sleep Unit group
This group will have standard follow up in sleep unit at 1, 3 and 6 month.
These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling.
|
|
|
実験的：Primary Care group
This group will have standard follow up in primary care at 1, 3 and 6 month.
These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling.
|
The study evaluates two different setting to follow up patients with obstructive sleep apnea on CPAP treatment
|
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 hours of use per day of CPAP
時間枠：Six month
|
Number of hours of use per day of CPAP according to the internal clock of the CPAP device
|
Six month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Daytime sleepiness
時間枠：At baseline and at 6 month of follow-up
|
Epworth Sleepiness Scale (ESS)
|
At baseline and at 6 month of follow-up
|
|
Patient satisfaction
時間枠：Six month
|
visual analog scale (0-10)
|
Six month
|
|
Adverse events
時間枠：Six month
|
Adverse events related to CPAP treatment
|
Six month
|
|
Quality of life
時間枠：Baseline and at 6 month of follow up
|
EuroQol
|
Baseline and at 6 month of follow up
|
|
Cost-efficacy evaluation
時間枠：Six month
|
Qualys
|
Six month
|
|
Comorbidity index
時間枠：Six month
|
Charlson index
|
Six month
|
|
Blood pressure
時間枠：Sixt month
|
Office blood pressure
|
Sixt month
|
|
Lost of follow up
時間枠：Six month
|
Percentage of patients lost during follow up
|
Six month
|
その他の成果指標
結果測定 |
時間枠 |
|---|---|
|
Body mass index
時間枠：Six month
|
Six month
|
協力者と研究者
捜査官
- スタディディレクター：Ferran Barbe, MD、Hospital Anrnau Vilanova- Santa Maria, Lleida (Spain)
- 主任研究者：Cristina Esquinas, RN, MPH、Hospital Arnau Vilanova-Santa Maria, Lleida (Spain)
- 主任研究者：Nuria Nadal, MD、Primary Care. National Health Institute. Lleida (Spain)
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 (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
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。