Efficiency of Intermittent Hypoxia Intervention in Primary Insomnia

NCT07394699 | Not Yet Recruiting

• 1 other identifier: IH-PI
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Insomnia, Primary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Concentration of serum parameters between IH group and control group

  Baseline and Day 7

• The score of Insomnia Severity Index（ISI）

  Baseline and Day 7

• The score of the Flinders Fatigue Scale (FFS)

  Baseline and Day 7

• The scale of Self-Rating Anxiety Scale (SAS)

  Baseline and Day 7

• The score of Self-Rating Depression Scale (SDS)

  Baseline and Day 7

Study Arms (2)

IH group

ACTIVE COMPARATOR

Participants will receive 10 times intermittent hypoxia (oxygen concentration: 13%) intervention.

Other: Intermittent Hypoxia

Control group

SHAM COMPARATOR

Participants will receive 10 times sham-hypoxia (oxygen concentration: 21%) intervention in 5 days.

Other: Sham Intermittent Hypoxia

Interventions

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.

IH group

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.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Yuan Wang

CONTACT

+86-13581567815; wilma0106@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: February 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-02