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Sleep to Lower Elevated Blood Pressure (SLEPT)

1 september 2014 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

134

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Ierland
      • Galway, Ierland
        • HRB Clinical Research Facility Galway

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: Online Sleep Education
Geen tussenkomst: Usual CV care
Specialist nurses will administer the CV risk factor education intervention to participants in small groups over one hour.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Systolic Blood Pressure
Tijdsspanne: 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

Secundaire uitkomstmaten

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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Body Mass Index
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 8 weeks
To determine if concomitant use of antihypertensive medication influences the change in mean 24-hour SBP over 8 weeks .
8 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University College Hospital Galway

Medewerkers

Health Research Board, Ireland

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2013

Primaire voltooiing (Werkelijk)

1 juni 2014

Studie voltooiing (Werkelijk)

1 juni 2014

Studieregistratiedata

Eerst ingediend

8 maart 2013

Eerst ingediend dat voldeed aan de QC-criteria

12 maart 2013

Eerst geplaatst (Schatting)

13 maart 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

3 september 2014

Laatste update ingediend die voldeed aan QC-criteria

1 september 2014

Laatst geverifieerd

1 september 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HRBCRFG-150213-EMG

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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