Sleep to Lower Elevated Blood Pressure (SLEPT)
1 de setembro de 2014 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
134
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Galway, Irlanda
- HRB Clinical Research Facility Galway
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Systolic Blood Pressure
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Diastolic Outcome Measure
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Body Mass Index
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Martin J O'Donnell, MB PhD, National University of Ireland, Galway
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2013
Conclusão Primária (Real)
1 de junho de 2014
Conclusão do estudo (Real)
1 de junho de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
8 de março de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de março de 2013
Primeira postagem (Estimativa)
13 de março de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
3 de setembro de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de setembro de 2014
Última verificação
1 de setembro de 2014
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HRBCRFG-150213-EMG
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