Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes

12. december 2019 opdateret af: Ashley Coombe, Emory University
The study is a prospective unblinded randomized trial to evaluate the feasibility of conducting a sleep extension intervention trial and the sleep extension intervention among the young adults. The study also wants to assess whether a sleep-extension intervention has an impact on the insulin resistance levels of young adults. The intervention consists of an education session and to extend the sleep time at least one hour but can be up to 2 hours per night for 4 weeks.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Insulin Resistance has been shown to put a person at risk for developing Type II diabetes. There is a correlation between sleep deprivation and insulin resistance.The study wants to assess the feasibility by enrolling 20 subjects in a year. The study also wants to assess the feasibility of the sleep extension intervention among young adults by examining the number of subjects that are randomized to intervention arm will complete the study.

Another intent of the study is to examine how sleep behaviors affect risks for developing type 2 diabetes and to determine their willingness to participate in a 4-week home-based program (intervention) focused on personal sleep behaviors.

Subjects enrolled in the study and are randomized to intervention group and control group. The intervention group will receive one education session consisting of strategies for sleep hygiene which is the routine for going to sleep and instructions on extending time in bed by at least one hour but can be up to 2 hours total per night for 4 weeks. At the end of 4 weeks subjects will have a blood draw and will complete the questionnaires.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

6

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30303
        • Georgia State University
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 25 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age must be 18-25 years old
  • Self-report short sleep
  • BMI ≥ 30 (the World Health Organization's classification of being obese)
  • Insulin Resistance determined by serum analysis
  • Be willing to extend time in bed by one hour total per night
  • Read and speak English.

Exclusion Criteria:

  • Night shift worker;
  • Sleep disorder diagnosis;
  • Medical diagnosis of diabetes or pre-diabetes;
  • Currently pregnant or lactating or with history of gestational diabetes;
  • Actively participating in a weight loss program;
  • Hospitalization in past 3 months for any medical or psychiatric condition;
  • Having a major chronic illness (e.g. cancer, Lupus)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Interventional Group

Intervention Group (SLEEP-Extend intervention): The SLEEP-Extend intervention consists of two components:

  1. One education session (5-10 minutes) consisting of strategies for sleep hygiene which is the routine for going to sleep (an investigator-developed brochure and information based on recommendations from the American Academy of Sleep Medicine and the National Sleep Foundation will be given and reviewed with the subject)
  2. Instructions on extending time in bed by at least one hour but can be up to 2 hours total per night for 4 weeks which can be accomplished by either going to bed earlier or staying in bed later (subject will decide what works best for them).
Adfærdsmæssigt: SLEEP-Extend intervention
  1. One education session (5-10 minutes) consisting of strategies for sleep hygiene which is the routine for going to sleep
  2. Instructions on extending time in bed by at least one hour but can be up to 2 hours total per night for 4 weeks which can be accomplished by either going to bed earlier or staying in bed later
Andet: Control Group
Control group: consists of One educational session (5-10 minutes) consisting of safety practices used for an urban environment (a safety brochure and safety information will be given and reviewed with the subject)
Andet: Control
Control group will receive 1. One educational session (5-10 minutes) consisting of safety practices used for an urban environment (a safety brochure and safety information will be given and reviewed with the subject)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Enrollments in the Study Over One Year
Tidsramme: Up to 12 months
Feasibility of the study is assessed by number of enrollments in the study over a one year period. Study proposes to enroll minimum 20 subjects to meet the feasibility of the study.
Up to 12 months
Number of Participants Enrolled in the Intervention Arm Who Complete the Study
Tidsramme: Week 4
Feasibility of the SLEEP-Extend intervention among young adults is measured by number of participants enrolled in the intervention arm that received the intervention and completed the study required protocols for the study duration of 4 weeks.
Week 4

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores
Tidsramme: Baseline, Week 4
The HOMA-IR score is used to measure severity of insulin resistance, though normal insulin resistance varies depending on the population. HOMA-IR is calculated as blood glucose level (nmol/L) multiplied by insulin level (microU/L), divided by 22.5. Elevated values indicate insulin resistance. A cutoff score of HOMA-IR < 2.1 is considered normal and HOMA-IR ≥ 2.1 is considered to be evidence of insulin resistance.
Baseline, Week 4
Hours of Sleep
Tidsramme: Over a 1 week period at Baseline, and over a 1 week period at Week 4
Using wrist actigraphy, this study will objectively monitor each participant's 24-hour sleep-wake cycle to obtain average sleep duration (total sleep time) over one week.
Over a 1 week period at Baseline, and over a 1 week period at Week 4
Number of Participants Extending Sleep
Tidsramme: Over a 1 week period at Baseline, and over a 1 week period at Week 4
Sleep extension is assessed as the number of participants extending their nightly sleep by 1 to 2 hours from the baseline visit to the week 4 visit, as monitored using wrist actigraphy to measure each participant's 24-hour sleep-wake cycle to obtain average sleep duration (total sleep time) over one week.
Over a 1 week period at Baseline, and over a 1 week period at Week 4

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Emory University

Samarbejdspartnere

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Efterforskere

  • Ledende efterforsker: Ashley Coombe, PhD, RN, CNE, Emory University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. august 2017

Primær færdiggørelse (Faktiske)

2. april 2018

Studieafslutning (Faktiske)

2. april 2018

Datoer for studieregistrering

Først indsendt

23. juli 2018

Først indsendt, der opfyldte QC-kriterier

31. juli 2018

Først opslået (Faktiske)

6. august 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. december 2019

Sidst verificeret

1. december 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00105390
  • 5P30DK111024-02 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner