NCT07394699

Efficiency of Intermittent Hypoxia Intervention in Primary Insomnia

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to understand the effectiveness of intermittent hypoxia in the treatment of primary insomnia.

Detailed description

Insomnia is a sleep disorder characterized by frequent and persistent difficulties in falling asleep or maintaining sleep, and resulting in inadequate sleep satisfaction. Insomnia is a common sleep problem with a prevalence of 10% to 15% in adults and a chronic course that may increase with age, with nearly half of those with severe insomnia lasting more than 10 years.Insomnia can increase the risk of some diseases, such as anxiety, depression, hypertension, diabetes and cardiovascular diseases. Insomnia is closely related to the body's chronic inflammatory response, and studies have shown that insomnia induces a chronic inflammatory response in the body, which impairs the structure and integrity of sleep, leading to an increased inflammatory response in the body, which in turn impairs the health. Intermittent hypoxia (IH) refers to periodic hypoxic-normoxic training performed with brief exposure to hypoxia. Previous studies have shown that short-term intermittent hypoxia can produce neuroprotective effects, inhibit inflammatory response, and promote neurological recovery, providing a new approach for the treatment of primary insomnia.

Conditions

• Insomnia, Primary

Interventions

Type	Name	Description
OTHER	Intermittent Hypoxia	The intermittent hypoxia protocol refers to four cycles of 5 minutes hypoxia inhaling interval by 5 minutes normoxia, which is performed twice a day (at least 6 hours apart) in 7 days.
OTHER	Sham Intermittent Hypoxia	The sham intermittent hypoxia protocol refers to 45 minutes normoxia inhaling, which is performed twice a day (at least 6 hours apart) in 7 days.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-02-06
• Last updated: 2026-02-06