NCT06648109

Effects of Sleep Body Temperature on Body Composition

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Jinan University Guangzhou · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

This will be a crossover controlled trial designed to recruit 40 participants, who will be divided into two groups of 20 subjects each. The participants will be randomly assigned to either Group A or Group B. Group A will receive the sleep electric blanket intervention for a period of 7 days, while Group B will serve as the control group without any additional intervention. After the intervention period, there will be a washout period of 7 days to ensure that any effects of the intervention have subsided before the crossover. Following the washout period, the groups will switch roles: Group B will then receive the sleep electric blanket intervention, and Group A will become the control group. This second phase will also last for 7 days, preceded and followed by the same assessment procedures as the initial phase. This design will allow for a comparison of the intervention's effects against a control period within the same group of participants, enhancing the study's internal validity.

Conditions

• Blood Pressure Check (Hypertension Screening)
• Heart Rate
• Aldosterone Disorder

Interventions

Type	Name	Description
DEVICE	Electric Blanket	Participants were randomized to groups A and B. When the subject\'s group cohort went through the intervention phase (instead of the control phase), they received a 7-day, 8-hour intervention with an electric blanket +5±1°C above room temperature.

Timeline

• Start date: 2024-10-20
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2024-10-18
• Last updated: 2024-10-18

Locations

1 site across 1 country: China