NCT06658171

Effects of Relaxation Training and Stimulus Control in Chronic Insomnia Patients

Effects of Relaxation Training and Stimulus Control in Chronic Insomnia Patients With Hyperarousal and Maladaptive Sleep Patterns

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study aims to validate the effect of relaxation training and stimulus control on reducing hyperarousal states and improving maladaptive sleep behaviors.

Detailed description

Relaxation training typically includes techniques such as breathing exercises, muscle relaxation, and mindfulness meditation to help patients reduce levels of physical and psychological tension, promote relaxation, and create favorable conditions for sleep onset. Stimulus control aims to break the negative association between the bed and insomnia, and rebuild a positive association between the bed and sleep.

Conditions

• Chronic Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Relaxation training and stimulus control	Relaxation training: Progressive muscle relaxation; Breathing relaxation; Imagery training; Mindfulness relaxation. Stimulus control: a) Reduce wakeful time in bed and rebuild a positive association between sleepiness and bed; b) Use the bed solely for sleeping and sexual activities; c) Only go to bed when feeling sleepy at night or at the designated sleep time; d) If unable to fall asleep within about 20 minutes of being in bed, leave the bedroom and engage in relaxation activities until feeling sleepy, then return to bed for sleep; if still unable to fall asleep within about 20 minutes, repeat the process; e) Wake up at the same time every morning, including weekends.
BEHAVIORAL	Sleep hygiene education	1. Sleep until feeling refreshed the next day. 2. Maintain regular exercise and eating habits, avoiding going to bed on an empty stomach. 3. Ensure a comfortable bedroom environment with suitable nighttime temperature, free from light and noise disturbances. 4. Avoid excessive consumption of beverages, alcohol, and smoking at night, and reduce caffeine intake. 5. Avoid bringing problems to bed and refrain from attempting to sleep. 6. Place the alarm clock under the bed or move it away from sight. 7. Avoid daytime napping.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-10-01
• Completion: 2025-11-01
• First posted: 2024-10-26
• Last updated: 2025-05-09

Locations

1 site across 1 country: China