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

12 de diciembre de 2019 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

6

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30303
        • Georgia State University
      • Atlanta, Georgia, Estados Unidos, 30322
        • Emory University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 25 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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).
Conductual: 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
Otro: 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)
Otro: 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)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Enrollments in the Study Over One Year
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Emory University

Colaboradores

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

Investigadores

  • Investigador principal: Ashley Coombe, PhD, RN, CNE, Emory University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

30 de agosto de 2017

Finalización primaria (Actual)

2 de abril de 2018

Finalización del estudio (Actual)

2 de abril de 2018

Fechas de registro del estudio

Enviado por primera vez

23 de julio de 2018

Primero enviado que cumplió con los criterios de control de calidad

31 de julio de 2018

Publicado por primera vez (Actual)

6 de agosto de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de diciembre de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

12 de diciembre de 2019

Última verificación

1 de diciembre de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IRB00105390
  • 5P30DK111024-02 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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