Efficiency of Intermittent Hypoxia Intervention in Primary Insomnia

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

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia, Primary
• Intervention / Treatment: Other: Intermittent Hypoxia; Other: Sham Intermittent Hypoxia

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuan Wang; Phone Number: +86-13581567815; Email: wilma0106@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IH group; Participants will receive 10 times intermittent hypoxia (oxygen concentration: 13%) intervention.	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.
Sham Comparator: Control group; Participants will receive 10 times sham-hypoxia (oxygen concentration: 21%) intervention in 5 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The polysomnography between IH group and control group	Before and after the experiment, polysomnography was performed on both the experimental and control groups to record sleep latency, total sleep duration, as well as the duration and proportion of each sleep stage.	Baseline and Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of serum parameters between IH group and control group	Measure tumor markers, IL-6, IL-1β, and other relevant indicators in both the experimental and control groups before and after the experiment.	Baseline and Day 7
The score of Insomnia Severity Index（ISI）	The Insomnia Severity Index (ISI) total score is included as a separate secondary outcome measure, with values on a scale ranging from 0 to 28, where higher scores indicate a worse outcome (greater severity of insomnia).	Baseline and Day 7
The score of the Flinders Fatigue Scale (FFS)	The Flinders Fatigue Scale (FFS) total score is included as a separate secondary outcome measure, with values on a scale ranging from 0 to 31, where higher scores indicate a worse outcome (greater fatigue severity).	Baseline and Day 7
The scale of Self-Rating Anxiety Scale (SAS)	The Self-Rating Anxiety Scale (SAS) total score is included as a separate secondary outcome measure, with values on a scale ranging from 25 to 100, where higher scores indicate a worse outcome (higher levels of anxiety).	Baseline and Day 7
The score of Self-Rating Depression Scale (SDS)	The Self-Rating Depression Scale (SDS) total score is included as a separate secondary outcome measure, with values on a scale ranging from 25 to 100, where higher scores indicate a worse outcome (higher levels of depression).	Baseline and Day 7
Peripheral Oxygen Saturation (SpO₂)	The Peripheral Oxygen Saturation (SpO₂) is included as a separate outcome measure, with values on a percentage scale ranging from 0% to 100%, where higher scores indicate a better outcome (higher level of blood oxygenation).	Day 1-7
Heart Rate	The Heart Rate is included as a separate outcome measure, measured in beats per minute (bpm). While there is no universal fixed range, values are assessed against normal clinical reference ranges, where extreme values (either too high or too low) indicate a worse outcome.	Day 1-7
Respiratory Rate	The Respiratory Rate is included as a separate outcome measure, measured in breaths per minute (brpm). While there is no universal fixed range, values are assessed against normal clinical reference ranges, where extreme values (either too high or too low) indicate a worse outcome.	Day 1-7
Blood Pressure	Blood Pressure is included as a separate outcome measure, measured in millimeters of mercury (mmHg) and reported as the combination of systolic and diastolic values. While there is no universal fixed range, values are assessed against normal clinical reference ranges, where extreme values (either too high or too low) indicate a worse outcome.	Day 1-7

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: IH-PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No