Efficiency of Intermittent Hypoxia Intervention in Primary Insomnia

Capital Medical University

Status: Begins enrollment in 1 month

Conditions: Insomnia, Primary

Treatments: Other: Sham Intermittent Hypoxia; Other: Intermittent Hypoxia

Study type: Interventional

Funder types: Other

Identifiers

NCT07394699

IH-PI

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects are diagnosed with primary insomnia between 18 and 60 years old，gender is not limited.
• Patients who are not taking sedative-hypnotic drugs or have stopped taking drugs for more than 2 weeks.
• Residing in the plains all year round and not having been above 1500 meters above sea level in the past 30 days.
• Quiet state SaO2 ≥ 90%, cerebral oxygen saturation 58-82%, heart rate 60-100 beats/min, blood pressure 90-140/60-90 mmHg, respiratory rate 16-20 times/min.
• No functional drinks, caffeine-containing beverages, or sleep-disturbing medications during the study period.

Exclusion criteria

• Stroke onset in the past 3 months, other severe neurological diseases, such as epilepsy, intracranial infectious diseases or demyelination.
• Uncontrolled hypertension (systolic blood pressure ≥200mmHg) with antihypertensive drugs before enrollment, other cardiovascular diseases.
• History of pulmonary, hepatic, dermatologic, or hematologic diseases.
• History of substance abuse.
• Pregnancy, Severe sleep apnea and neurological disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

IH group

Active Comparator group

Description:

Participants will receive 10 times intermittent hypoxia (oxygen concentration: 13%) intervention.

Treatment:

Other: Intermittent Hypoxia

Control group

Sham Comparator group

Description:

Participants will receive 10 times sham-hypoxia (oxygen concentration: 21%) intervention in 5 days.

Treatment:

Other: Sham Intermittent Hypoxia