Insomnia, PrimaryNCT07394699
Efficiency of Intermittent Hypoxia Intervention in Primary Insomnia
A study testing Intermittent Hypoxia in people with Insomnia, Primary, run by Capital Medical University.
Trial summary
The purpose of this study was to understand the effectiveness of intermittent hypoxia in the treatment of primary insomnia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Insomnia, Primary
- What is being tested?
- Intermittent Hypoxia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study was to understand the effectiveness of intermittent hypoxia in the treatment of primary insomnia.
Read the 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.
- Conditions
- Insomnia, Primary
- Being tested
- Intermittent Hypoxia, Sham Intermittent Hypoxia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent HypoxiaOther
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 HypoxiaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| IH group | Active comparator | Participants will receive 10 times intermittent hypoxia (oxygen concentration: 13%) intervention. Receives: Other: Intermittent Hypoxia |
| Control group | Sham comparator | Participants will receive 10 times sham-hypoxia (oxygen concentration: 21%) intervention in 5 days. Receives: Other: Sham Intermittent Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 7
Secondary outcomes (9)
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia, PrimaryStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394699
- Sponsor's protocol ID
- IH-PI
- Status last verified
- Feb 2026
- First submitted
- 5 May 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Intermittent Hypoxia Intervention in Primary Insomnia
- ClinicalTrials.gov ID
- NCT07394699
- Acronym / sponsor ID
- IH-PI
- Conditions
- Insomnia, Primary
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IH group | Active comparator | Other: Intermittent HypoxiaParticipants will receive 10 times intermittent hypoxia (oxygen concentration: 13%) intervention. |
| Control group | Sham comparator | Other: Sham Intermittent HypoxiaParticipants will receive 10 times sham-hypoxia (oxygen concentration: 21%) intervention in 5 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent HypoxiaThe 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 | IH group |
| Sham Intermittent HypoxiaThe sham intermittent hypoxia protocol refers to 45 minutes normoxia inhaling, which is performed twice a day (at least 6 hours apart) in 7 days. | Other | Control group |
Primary outcome
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Hypoxia in people with Insomnia, Primary, run by Capital Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan Wang (+86-13581567815, wilma0106@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The polysomnography between IH group and control group (time frame: Baseline and Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.