- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01809821
Sleep to Lower Elevated Blood Pressure (SLEPT)
1. september 2014 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
134
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Galway, Irland
- HRB Clinical Research Facility Galway
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Systolic Blood Pressure
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Diastolic Outcome Measure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Body Mass Index
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Martin J O'Donnell, MB PhD, National University of Ireland, Galway
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2013
Primær fullføring (Faktiske)
1. juni 2014
Studiet fullført (Faktiske)
1. juni 2014
Datoer for studieregistrering
Først innsendt
8. mars 2013
Først innsendt som oppfylte QC-kriteriene
12. mars 2013
Først lagt ut (Anslag)
13. mars 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
3. september 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. september 2014
Sist bekreftet
1. september 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HRBCRFG-150213-EMG
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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