Efficiency of Intermittent Hypoxia Intervention in Primary Insomnia
ConditionInsomnia, Primary
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCapital Medical University
About this trial
The purpose of this study was to understand the effectiveness of intermittent hypoxia in the treatment of primary insomnia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Intermittent Hypoxia
Other interventionThe 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 interventionThe sham intermittent hypoxia protocol refers to 45 minutes normoxia inhaling, which is performed twice a day (at least 6 hours apart) in 7 days.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: IH groupActive comparator 1 intervention
Group B: Control groupSham comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and Day 7Secondary outcomes
1
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.
Time frame
Baseline and Day 72
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).
Time frame
Baseline and Day 73
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).
Time frame
Baseline and Day 74
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).
Time frame
Baseline and Day 7Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: