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临床试验/NCT05066581
NCT05066581已完成不适用

Vitoria Sleep Smart City: Interactive Intervention for Sleep Improvement.

Hospital Universitario Araba2 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2021年6月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
202
试验地点
2
主要终点
Total sleep time

研究概览

简要总结

Currently, the investigators know that there is a high and increasing prevalence of sleep quality and quantity deficits in the general population with the social and health consequences that this entails. There are numerous activity wristbands linked to mobile apps that analyze sleep, but none can generate individualized recommendations for improvement interacting with the person. The main objective of the current project is to develop a virtual and interactive sleep assistant to increase the quantity and quality of sleep. Secondary objectives being the improvement of daytime sleepiness and the quality of life of the persons.

Methodology: 202 participants in active employment who meet the criteria of "poor sleepers" (defined by a Pittsburg test score >5) are divided into 2 study groups. 1. Intervention group: Sleep data will be collected using validated questionnaires (SATED and the Sleep Hygiene Index) and objectively employing an activity bracelet, in which weekly, through a live chat, the medical staff of the sleep units will offer recommendations for the improvement of the deficits detected. 2. Control group: Same protocol as the intervention group, but the participants will not receive the recommendations via the interactive chat.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 to 65 years

排除标准

  • Patients previously diagnosed and treated for sleep pathology (such as insomnia, Obstructive Sleep Apnea (OSA), Restless Legs Syndrome (RLS), narcolepsy or parasomnia, among others).
  • Severe medical or psychiatric comorbidities.
  • Subjects who are not capable of using mobile technology such as Smartphone.
  • Subjects who are not committed to actively participate, putting into practice the sleep recommendations given by the assistant.

结局指标

主要结局

Total sleep time

时间窗: Eight months

By measuring total sleep time, determine the objective of sleeping between 7 and 9 hours per day on average.

次要结局

未报告次要终点

研究者

发起方
Hospital Universitario Araba
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Javier Egea Santaolalla,Ph

HEAD OF FUNCTIONAL SLEEP UNIT

Hospital Universitario Araba

研究点 (2)

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