Sleep to Lower Elevated Blood Pressure (SLEPT)
1. září 2014 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
134
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Galway, Irsko
- HRB Clinical Research Facility Galway
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Žádný zásah: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Systolic Blood Pressure
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Diastolic Outcome Measure
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Body Mass Index
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Martin J O'Donnell, MB PhD, National University of Ireland, Galway
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. května 2013
Primární dokončení (Aktuální)
1. června 2014
Dokončení studie (Aktuální)
1. června 2014
Termíny zápisu do studia
První předloženo
8. března 2013
První předloženo, které splnilo kritéria kontroly kvality
12. března 2013
První zveřejněno (Odhad)
13. března 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
3. září 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. září 2014
Naposledy ověřeno
1. září 2014
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HRBCRFG-150213-EMG
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .