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Not yet recruiting NCT07394699

Efficiency of Intermittent Hypoxia Intervention in Primary Insomnia

No phase Interventional Insomnia, Primary

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intermittent Hypoxia, Sham Intermittent Hypoxia.
Who it may be relevant to
Registry conditions: Insomnia, Primary. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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.

Primary outcome measures

  • The polysomnography between IH group and control group [Time frame: Baseline and Day 7]
Secondary outcome measures (9)
  • Concentration of serum parameters between IH group and control group [Time frame: Baseline and Day 7]
  • The score of Insomnia Severity Index（ISI） [Time frame: Baseline and Day 7]
  • The score of the Flinders Fatigue Scale (FFS) [Time frame: Baseline and Day 7]
  • The scale of Self-Rating Anxiety Scale (SAS) [Time frame: Baseline and Day 7]
  • The score of Self-Rating Depression Scale (SDS) [Time frame: Baseline and Day 7]
  • Peripheral Oxygen Saturation (SpO₂) [Time frame: Day 1-7]
  • Heart Rate [Time frame: Day 1-7]
  • Respiratory Rate [Time frame: Day 1-7]
  • Blood Pressure [Time frame: Day 1-7]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07394699 · IH-PI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗