Sleep to Lower Elevated Blood Pressure (SLEPT)
2014年9月1日 更新者：Dr. Emer McGrath、University College Hospital Galway
Sleep to Lower Elevated Blood Pressure: A Randomised Controlled Trial
Sleep is an essential component of good physical and mental health.
Previous studies have reported that poor quality sleep is associated with an increased risk of hypertension, stroke and cardiovascular disease (CVD).
Hypertension is the most common and important risk factor for CVD, and even modest reductions in blood pressure result in significant reductions in stroke and myocardial infarction.
In this randomised trial, the investigators aim to evaluate whether a simple, multi-component, online sleep intervention reduces blood pressure in patients with essential hypertension.
調査の概要
研究の種類
介入
入学 (実際)
134
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Galway、アイルランド
- HRB Clinical Research Facility Galway
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Signed written informed consent
- ≥18 years on entry to study
- Average automated Systolic Blood Pressure (SBP) monitor readings between 130 - 160 mmHg with average automated Diastolic Blood Pressure(DBP) monitor readings <110 mmHg on three occasions, measured in a valid standardized manner while seated, or average Ambulatory Blood Pressure Monitor (ABPM) SBP reading between 130-160 mmHg with average DBP reading <110 mmHg.
- Self-reported difficulty getting to sleep (defined as usually taking more than 30 mins to get to sleep), and/or staying asleep (usually waking up more than once per night) for at least 3 months duration
- Internet access and self-reported competency in using the internet
Exclusion Criteria:
- Receiving > 2 antihypertensive medications, or recent change in antihypertensive medications (within previous 2 months) or planned change in antihypertensive medication in next 8 weeks
- Previous history of myocardial infarction, ischaemic stroke or transient ischaemic attack
- Previous history of congestive heart failure
- History of dialysis for chronic renal impairment or evidence of chronic kidney disease (eGFR <60 or albuminuria).
- Known history of diabetes mellitus
- Current ongoing sleep hygiene education or sleep related cognitive behavioural therapy
- Ongoing involvement in night shift work
- History of obstructive sleep apnoea (OSA) and previously received or currently receiving treatment for OSA (patients with a history of untreated OSA are eligible for inclusion).
- Known history of sleep disorders (i.e. narcolepsy; hypersomnias; parasomnias such as sleep walking, night terrors, recurring nightmares; periodic limb movements/restless leg syndrome; circadian rhythm sleep disorder)
- Unable to follow educational advice in the opinion of the clinician
- Baby or young children at home that wake during the night
- History of bipolar affective disorder
- History of psychosis
- History of major depression (defined as depression requiring hospitalization in the past or visit to psychiatry outpatient clinic in the past 3 months)
- Unstable depression (unstable will be defined as changes in antidepressant medications within the last 3 months - i.e. start, stop or change in dose.)
- Unstable anxiety disorders/panic attacks (unstable will be defined as changes in medications within the last 3 months - i.e. start, stop or change in dose.)
- Ongoing substance or alcohol abuse
- Planned surgery or hospitalization over the next 8 weeks (i.e. during the trial)
- Incapacitating pain or illness or other medical condition in which, in the opinion of the clinician, the sleep intervention is unlikely to be effective.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Online Sleep Education
The sleep intervention is a multi-component online intervention consisting of sleep information and sleep hygiene education, along with behavioural and cognitive components.
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介入なし：Usual CV care
Specialist nurses will administer the CV risk factor education intervention to participants in small groups over one hour.
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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 |
|---|---|---|
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Systolic Blood Pressure
時間枠：8 weeks
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To determine if the addition of a multi-component, online, sleep intervention to usual care (standard CV risk factor education), results in a greater reduction in mean 24-hr systolic blood pressure in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8-week period.
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8 weeks
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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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Diastolic Outcome Measure
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a greater reduction in mean 24-hr diastolic blood pressure in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8-week period?
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8 weeks
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Sleep efficiency
時間枠：8 weeks
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Change in proportion of participants with sleep efficacy ≥ 85% at 8 weeks
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8 weeks
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Sleep onset latency
時間枠：8 weeks
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Change in proportion of participants with sleep onset latency ≤ 30 minutes at 8 weeks
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8 weeks
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PSQI
時間枠：8 weeks
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Change in proportion of participants with Pittsburgh Sleep Quality Index (PSQI) score <5 over 8 weeks
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8 weeks
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SCI
時間枠：8 weeks
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Change in proportion of participants with sleep condition indicator (SCI) score ≤5.9 at 8 weeks
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8 weeks
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ISI
時間枠：8 weeks
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Change in proportion of participants with Insomnia Severity index (ISI) score ≥15 at 8 weeks
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8 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Body Mass Index
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in body mass index in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
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8 weeks
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Plasma lipoproteins
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in plasma lipids in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
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8 weeks
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Plasma HbA1c
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in plasma HbA1c in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
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8 weeks
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eGFR
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in eGFR in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
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8 weeks
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Insomnia Severity Index
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in Insomnia Severity Index Score in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
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8 weeks
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Sleep Condition Indicator Score
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in Sleep Condition Indicator Score in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
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8 weeks
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Pittsburgh Sleep Quality Index
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in Pittsburgh Sleep Quality Index in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
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8 weeks
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Mean number of cigarettes smoked
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in mean number of cigarettes smoked in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
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8 weeks
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Sleep onset latency
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in sleep onset latency in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
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8 weeks
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Wake time to sleep onset
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in wake time to sleep onset in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
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8 weeks
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Sleep efficiency
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in sleep efficiency in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
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8 weeks
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Beck Depression Inventory score
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in Beck Depression Inventory score in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
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8 weeks
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Beck Anxiety Inventory score
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in Beck Anxiety Inventory score in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
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8 weeks
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Smoking status
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in smoking status compared to usual care alone, over an 8 week period?
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8 weeks
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Diastolic blood pressure
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in daytime (peak and mean) diastolic blood pressure , compared to usual care alone, over an 8 week period?
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8 weeks
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Systolic blood pressure
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in daytime (peak and mean) systolic blood pressure , compared to usual care alone, over an 8 week period?
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8 weeks
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Total Sleep Time
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in Total Sleep Time , compared to usual care alone, over an 8 week period?
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8 weeks
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Diastolic blood pressure
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in nighttime (peak and mean) diastolic blood pressure , compared to usual care alone, over an 8 week period?
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8 weeks
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Systolic blood pressure
時間枠：8 weeks
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Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in nighttime (peak and mean) systolic blood pressure , compared to usual care alone, over an 8 week period?
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8 weeks
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Systolic blood pressure
時間枠：8 weeks
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Is the level of adherence to a multi-component online sleep intervention associated with a change in mean 24-hour SBP over 8 weeks
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8 weeks
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Systolic blood pressure
時間枠：8 weeks
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To determine if concomitant use of antihypertensive medication influences the change in mean 24-hour SBP over 8 weeks .
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8 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Martin J O'Donnell, MB PhD、National University of Ireland, Galway
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年5月1日
一次修了 (実際)
2014年6月1日
研究の完了 (実際)
2014年6月1日
試験登録日
最初に提出
2013年3月8日
QC基準を満たした最初の提出物
2013年3月12日
最初の投稿 (見積もり)
2013年3月13日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年9月3日
QC基準を満たした最後の更新が送信されました
2014年9月1日
最終確認日
2014年9月1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。