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The purpose of this study was to understand the effectiveness of intermittent hypoxia in the treatment of primary insomnia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IH group | Active Comparator | Participants will receive 10 times intermittent hypoxia (oxygen concentration: 13%) intervention. |
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| Control group | Sham Comparator | Participants will receive 10 times sham-hypoxia (oxygen concentration: 21%) intervention in 5 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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） |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan Wang | Contact | +86-13581567815 | wilma0106@163.com |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| 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. |
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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 |
| D001523 |
| Mental Disorders |