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NCT Number: NCT07394699

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.

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Key information

Conditions

Insomnia, Primary Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intermittent Hypoxia

Other

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 Intermittent Hypoxia

Other

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.

Primary outcomes

  1. The polysomnography between IH group and control group

    Time frame: Baseline and Day 7

    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.

Secondary outcomes

  1. Concentration of serum parameters between IH group and control group

    Time frame: Baseline and Day 7

    Measure tumor markers, IL-6, IL-1β, and other relevant indicators in both the experimental and control groups before and after the experiment.

  2. The score of Insomnia Severity Index（ISI）

    Time frame: Baseline and Day 7

    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).

  3. The score of the Flinders Fatigue Scale (FFS)

    Time frame: Baseline and Day 7

    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).

  4. The scale of Self-Rating Anxiety Scale (SAS)

    Time frame: Baseline and Day 7

    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).

  5. The score of Self-Rating Depression Scale (SDS)

    Time frame: Baseline and Day 7

    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).

  6. Peripheral Oxygen Saturation (SpO₂)

    Time frame: Day 1-7

    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).

  7. Heart Rate

    Time frame: Day 1-7

    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.

  8. Respiratory Rate

    Time frame: Day 1-7

    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.

  9. Blood Pressure

    Time frame: Day 1-7

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuan Wang

CONTACT

[email protected]

+86-13581567815

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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