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临床试验/NCT05816434
NCT05816434已完成不适用

Can More Sleep Improve Pain Responses, Symptomatology, and Regulation in College Students?

Penn State University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年3月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Change in thermal pain tolerance from before to after sleep extension

研究概览

简要总结

This study is being done to find out whether extending sleep for at least an hour per night, seven days a week, predicts a higher tolerance and a higher threshold for pain. This is a 21-day study. Participants will be asked to wear sleep- and heart- monitoring watches. Pressure pain and cold pain will be measured at study visits.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 24 (inclusive) years of age at enrollment
  • Fluent English speaker and reader
  • Willing to refrain from initiating new therapeutic interventions (e.g., medication; behavioral) designed to target sleep or pain for the duration of study participation

排除标准

  • Diagnosed with a sleep disorder
  • Diagnosed with a pain disorder
  • Has experienced a cold-related injury frostbite or has any other nerve damage to the feet
  • Has a history of injury to any of the muscular measurement sites for pain (I.e. shoulder, jaw, forearm)
  • Diagnosed with hypertension or cardiovascular disease
  • Evidence of hypertension
  • Diagnosed serious mental health disorder or substance use disorder
  • Taking any physician-directed pharmacologic intervention for sleep
  • Taking any physician-directed pharmacologic intervention for pain
  • Personal health history of traumatic brain injury
  • Current smoker

研究组 & 干预措施

Sleep Extension

Experimental

1 week of >1 hour increased time in bed

干预措施: Sleep extension (Behavioral)

Control

No Intervention

Sustained sleep behavior

结局指标

主要结局

Change in thermal pain tolerance from before to after sleep extension

时间窗: Momentary at study visit 2 (at the end of week1) and a week later at study visit 3 (at the end of week2).

Latency to respond to a bilateral cold pressor test (feet). A longer latency to tolerance indicates better pain response.

Change in pressure pain threshold from before to after sleep extension

时间窗: Momentary at study visit 2 (at the end of week1) and a week later at study visit 3 (at the end of week2).

Bilateral response to a clinically standard algometer at 3 different physical palpation sites. A higher pressure reading indicates a better pain response.

Change in pain inhibition from before to after sleep extension

时间窗: Momentary at study visit 2 (at the end of week1) and a week later at study visit 3 (at the end of week2).

Pain inhibition is measured as the difference in pressure pain threshold from before to after cold pressor procedure. A reduction in pressure pain threshold is typical after cold pressor procedure. A greater reduction in pain threshold indicates a better response of the pain inhibitory system.

Change in pressure pain tolerance from before to after sleep extension

时间窗: Momentary at study visit 2 (at the end of week1) and a week later at study visit 3 (at the end of week2).

Bilateral response to a clinically standard algometer at 3 different physical palpation sites. A higher pressure reading indicates a better pain response.

Change in weekly average of momentary pain self-reports from before to after sleep extension

时间窗: (averaged) Daily surveys during study week 1 (pre-intervention) and study week 2 (intervention)

Intermittent pain intensity using a Visual Analog Scale (0-100, where 0 = "no pain", 100 = "worst pain imaginable in current circumstances"). Higher values indicated more pain, and a negative change indicates a decrease in pain.

Change in thermal pain threshold from before to after sleep extension

时间窗: Momentary at study visit 2 (at the end of week1) and a week later at study visit 3 (at the end of week2).

Latency to respond to a bilateral cold pressor test (feet). A longer latency to threshold indicates better pain response.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne-Marie Chang

Associate Professor

Penn State University

研究点 (1)

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