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Sleep to Lower Elevated Blood Pressure (SLEPT)

1 września 2014 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

134

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Irlandia
      • Galway, Irlandia
        • HRB Clinical Research Facility Galway

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: Online Sleep Education
Brak interwencji: Usual CV care
Specialist nurses will administer the CV risk factor education intervention to participants in small groups over one hour.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Systolic Blood Pressure
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Diastolic Outcome Measure
Ramy czasowe: 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
Ramy czasowe: 8 weeks
Change in proportion of participants with sleep efficacy ≥ 85% at 8 weeks
8 weeks
Sleep onset latency
Ramy czasowe: 8 weeks
Change in proportion of participants with sleep onset latency ≤ 30 minutes at 8 weeks
8 weeks
PSQI
Ramy czasowe: 8 weeks
Change in proportion of participants with Pittsburgh Sleep Quality Index (PSQI) score <5 over 8 weeks
8 weeks
SCI
Ramy czasowe: 8 weeks
Change in proportion of participants with sleep condition indicator (SCI) score ≤5.9 at 8 weeks
8 weeks
ISI
Ramy czasowe: 8 weeks
Change in proportion of participants with Insomnia Severity index (ISI) score ≥15 at 8 weeks
8 weeks

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Body Mass Index
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 8 weeks
To determine if concomitant use of antihypertensive medication influences the change in mean 24-hour SBP over 8 weeks .
8 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University College Hospital Galway

Współpracownicy

Health Research Board, Ireland

Śledczy

  • Główny śledczy: Martin J O'Donnell, MB PhD, National University of Ireland, Galway

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 maja 2013

Zakończenie podstawowe (Rzeczywisty)

1 czerwca 2014

Ukończenie studiów (Rzeczywisty)

1 czerwca 2014

Daty rejestracji na studia

Pierwszy przesłany

8 marca 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 marca 2013

Pierwszy wysłany (Oszacować)

13 marca 2013

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

3 września 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 września 2014

Ostatnia weryfikacja

1 września 2014

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • HRBCRFG-150213-EMG

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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