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临床试验/NCT07201935
NCT07201935尚未招募不适用

Hot, Cold, and Combined Thermodynamic Exposure to Improve Sleep Quality Among Military Cadets

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
试验地点
1
主要终点
Brief Mood Introspection Scale

研究概览

简要总结

This pilot study investigates the effects of cold-water immersion, traditional sauna use, and their combination on sleep architecture and psychological health in military cadets. The study uses wearable technologies including the Oura Ring to collect objective sleep and physiological data.

详细描述

The study will enroll 45 military cadets from The Citadel Military College, randomized into three groups: Cold-Water Immersion (CWI), High Heat Sauna (HHS), and Combined (COM). Participants will undergo a 7-day baseline period followed by a 14-day intervention. Sleep architecture and psychological-affective health will be assessed using validated wearable devices and questionnaires. The study aims to identify intervention-specific improvements in sleep and psychological health.

研究设计

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

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria
  • 18 - 30 years of age
  • Enrolled military cadet at the Citadel Military College.
  • Access to a smartphone with access to appropriate app marketplace (Apple iOS 15, Android 8.0 or newer) and reliable data access.
  • Ability to access and operate Oura Ring application.

排除标准

  • Medical contraindications to continuous wearing of the Oura Ring.
  • Current diagnosis of neurological conditions that impact vascular blood flow or the individual's ability to regulate temperature.
  • History of cardio-vascular conditions or history of poor blood circulation.
  • History of heat stroke or known sensitivity to hot/cold environments.
  • Currently taking medications that impair fluid balance, thermoregulation, blood flow, respiration, or heart rate.
  • Known dermatological disease aggravated by changes in temperature.
  • Pregnant or trying to become pregnant within the study timeframe. Urine samples will be provided by interested female cadets to ensure they are not pregnant.

研究组 & 干预措施

High heat sauna

Experimental

20 minutes of high heat sauna at 90 - 94C° (190 - 201.2F°) between 5:00 - 7:00pm

干预措施: High Heat Sauna (Behavioral)

Combination

Experimental

5 minutes of cold-water immersion (submerged up to chin) at 8 - 10C°(46.4 - 50F°) in the morning between 6:00 - 8:00am and 20 minutes of high heat sauna at 90 - 94C° (190 - 201.2F°) between 5:00 - 7:00pm

干预措施: Cold Water Immersion (Behavioral)

Combination

Experimental

5 minutes of cold-water immersion (submerged up to chin) at 8 - 10C°(46.4 - 50F°) in the morning between 6:00 - 8:00am and 20 minutes of high heat sauna at 90 - 94C° (190 - 201.2F°) between 5:00 - 7:00pm

干预措施: High Heat Sauna (Behavioral)

Cold-water immersion

Experimental

5 minutes of cold-water immersion (submerged up to chin) at 8 - 10C°(46.4 - 50F°) in the morning between 6:00 - 8:00am.

干预措施: Cold Water Immersion (Behavioral)

结局指标

主要结局

Brief Mood Introspection Scale

时间窗: At the end of the baseline monitoring phase (Day 7), end of intervention week 1 (Day 14), and end of intervention phase (Day 28)

Self-reported assessment of mood consisting of 16 mood adjectives. Participants rate each adjective on a 4-point likert scale (1 = definitely don't feel, 4 = definitely feel). The scale uses a combination of direct and reverse scoring so that higher scores reflect more favorable mood states (max = 64).

Glymphatic clearance

时间窗: End of baseline monitoring phase (Day 7), end of intervention week 1 (Day 14), and end of intervention (Day 28)

Changes in parenchymal resistance during sleep

Sleep Efficiency

时间窗: Each night of the baseline monitoring period (7days) and intervention phase (14days)

Percentage of sleep period spent asleep measured by the Oura Ring (percentage, %)

Pittsburgh Sleep Quality Index

时间窗: At the end of the baseline monitoring phase (Day 7), end of intervention week 1 (Day 14), and end of intervention phase (Day 28)

Self-reported sleep quality

Profile of Mood States: Total Mood Disturbance

时间窗: At the end of the baseline monitoring phase (Day 7), end of intervention week 1 (Day 14), and end of intervention phase (Day 28)

Self-reported mood disturbance used by summing all negative profiled mood sub-scores (tension, depression, anger/hostility, fatigue, and confusion) and subtracting the positive profiled mood sub-score (vigor). (score -32 - 200, higher equals greater mood disturbance)

次要结局

  • REM Sleep Duration(Each night of the baseline monitoring period (7days) and intervention phase (14days))
  • Deep Sleep Duration(Each night of the baseline monitoring period (7days) and intervention phase (14days))
  • Total Sleep Duration(Each night of the baseline monitoring period (7days) and intervention phase (14days))
  • Light Sleep Duration(Each night of the baseline monitoring period (7days) and intervention phase (14days))
  • Profile of Mood States: Confusion(End of baseline monitoring period (Day 7), end of intervention week 1 (Day 14), and end of intervention (Day 28))
  • Wake After Sleep Onset (WASO) Duration(Each night of the baseline monitoring period (7days) and intervention phase (14days))
  • Profile of Mood States: Tension/Anxiety(End of baseline monitoring period (Day 7), end of intervention week 1 (Day 14), and end of intervention (Day 28).)
  • Restless Sleep Duration(Each night of the baseline monitoring period (7days) and intervention phase (14days))
  • RMSSD(Each night of the baseline monitoring period (7days) and intervention phase (14days))
  • Nighttime Skin Temperature(Each night of the baseline monitoring period (7days) and intervention phase (14days))
  • Sleep Time Heart Rate(Each night of the baseline monitoring period (7days) and intervention phase (14days))
  • Profile of Mood States: Depression(End of baseline monitoring period (Day 7), end of intervention week 1 (Day 14), and end of intervention (Day 28))
  • Profile of Mood States: Anger/Hostility(End of baseline monitoring period (Day 7), end of intervention week 1 (Day 14), and end of intervention (Day 28))
  • Profile of Mood States: Vigor(End of baseline monitoring period (Day 7), end of intervention week 1 (Day 14), and end of intervention (Day 28))
  • Profile of Mood States: Fatigue(End of baseline monitoring period (Day 7), end of intervention week 1 (Day 14), and end of intervention (Day 28))

研究者

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

Mark Rosenberg

Assistant Professor

Medical University of South Carolina

研究点 (1)

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