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Sleep to Lower Elevated Blood Pressure (SLEPT)

1 сентября 2014 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

134

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Ирландия
      • Galway, Ирландия
        • HRB Clinical Research Facility Galway

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Тройной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Поведенческий: Online Sleep Education
Без вмешательства: Usual CV care
Specialist nurses will administer the CV risk factor education intervention to participants in small groups over one hour.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Systolic Blood Pressure
Временное ограничение: 8 weeks
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.
8 weeks

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Diastolic Outcome Measure
Временное ограничение: 8 weeks
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?
8 weeks
Sleep efficiency
Временное ограничение: 8 weeks
Change in proportion of participants with sleep efficacy ≥ 85% at 8 weeks
8 weeks
Sleep onset latency
Временное ограничение: 8 weeks
Change in proportion of participants with sleep onset latency ≤ 30 minutes at 8 weeks
8 weeks
PSQI
Временное ограничение: 8 weeks
Change in proportion of participants with Pittsburgh Sleep Quality Index (PSQI) score <5 over 8 weeks
8 weeks
SCI
Временное ограничение: 8 weeks
Change in proportion of participants with sleep condition indicator (SCI) score ≤5.9 at 8 weeks
8 weeks
ISI
Временное ограничение: 8 weeks
Change in proportion of participants with Insomnia Severity index (ISI) score ≥15 at 8 weeks
8 weeks

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Body Mass Index
Временное ограничение: 8 weeks
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?
8 weeks
Plasma lipoproteins
Временное ограничение: 8 weeks
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?
8 weeks
Plasma HbA1c
Временное ограничение: 8 weeks
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?
8 weeks
eGFR
Временное ограничение: 8 weeks
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?
8 weeks
Insomnia Severity Index
Временное ограничение: 8 weeks
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?
8 weeks
Sleep Condition Indicator Score
Временное ограничение: 8 weeks
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?
8 weeks
Pittsburgh Sleep Quality Index
Временное ограничение: 8 weeks
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?
8 weeks
Mean number of cigarettes smoked
Временное ограничение: 8 weeks
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?
8 weeks
Sleep onset latency
Временное ограничение: 8 weeks
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?
8 weeks
Wake time to sleep onset
Временное ограничение: 8 weeks
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?
8 weeks
Sleep efficiency
Временное ограничение: 8 weeks
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?
8 weeks
Beck Depression Inventory score
Временное ограничение: 8 weeks
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?
8 weeks
Beck Anxiety Inventory score
Временное ограничение: 8 weeks
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?
8 weeks
Smoking status
Временное ограничение: 8 weeks
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?
8 weeks
Diastolic blood pressure
Временное ограничение: 8 weeks
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?
8 weeks
Systolic blood pressure
Временное ограничение: 8 weeks
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?
8 weeks
Total Sleep Time
Временное ограничение: 8 weeks
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?
8 weeks
Diastolic blood pressure
Временное ограничение: 8 weeks
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?
8 weeks
Systolic blood pressure
Временное ограничение: 8 weeks
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?
8 weeks
Systolic blood pressure
Временное ограничение: 8 weeks
Is the level of adherence to a multi-component online sleep intervention associated with a change in mean 24-hour SBP over 8 weeks
8 weeks
Systolic blood pressure
Временное ограничение: 8 weeks
To determine if concomitant use of antihypertensive medication influences the change in mean 24-hour SBP over 8 weeks .
8 weeks

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University College Hospital Galway

Соавторы

Health Research Board, Ireland

Следователи

  • Главный следователь: Martin J O'Donnell, MB PhD, National University of Ireland, Galway

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 мая 2013 г.

Первичное завершение (Действительный)

1 июня 2014 г.

Завершение исследования (Действительный)

1 июня 2014 г.

Даты регистрации исследования

Первый отправленный

8 марта 2013 г.

Впервые представлено, что соответствует критериям контроля качества

12 марта 2013 г.

Первый опубликованный (Оценивать)

13 марта 2013 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

3 сентября 2014 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

1 сентября 2014 г.

Последняя проверка

1 сентября 2014 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • HRBCRFG-150213-EMG

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Online Sleep Education

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