Efficacy and Safety Evaluation of Remote Ischemic Adaptation ( Intermittent Pressure Stimulation ) in the Treatment of Insomnia After Stroke

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSecond Affiliated Hospital of Nanchang University

About this trial

The incidence of post-stroke depression is high, which will affect the rehabilitation of neurological function, damage cognitive function, and increase the risk of subsequent stroke recurrence. The guidelines recommend that in addition to antiplatelet, blood pressure control, lipid-lowering and other treatments, secondary prevention of post-stroke depression should also be strengthened. Moreover, after the occurrence of post-stroke depression, methods such as medication and psychotherapy have their own limitations, such as potential adverse drug reactions and limited psychotherapy. Therefore, it is necessary to pay attention to the prevention of post-stroke depression.

The remote ischemic adaptation therapy applied in our study is a safe, non-invasive and convenient physical therapy. By transiently and repeatedly applying ischemia-reperfusion stimulation to both upper arms, it induces a systemic protective response, improves the brain 's tolerance to ischemia and hypoxia, and exerts a protective effect on multiple organs such as the brain and heart. The RIC therapeutic instrument has been national patented and has been maturely applied to the prevention and treatment of acute cerebral infarction, which can promote the rehabilitation of neurological function. In addition, it also has certain curative effect in the treatment of cerebrovascular stenosis, refractory hypertension, depression, insomnia, anxiety and so on.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80 years old ;

In line with the diagnostic criteria of ischemic stroke, with reference to the ' Chinese guidelines for the diagnosis and treatment of acute ischemic stroke ' diagnosed ischemic stroke ;

Despite adequate sleep opportunities, patients still have difficulty in falling asleep or maintaining sleep, staying asleep at least 3 times a week for at least 3 months, which leads to pain or impaired daytime function.

PSQI score ≥ 6 and ISI score ≥ 8 ;

Disqualifiers

Insomnia before stroke ;

Patients with mental disorders, bipolar disorder or depression, generalized anxiety disorder and other mental disorders ;

Patients were pregnant or lactating women ;

Other reasons identified by the researchers are not suitable for patients ;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Automatic ischemic preconditioning therapeutic apparatus

    Device

    The patient 's upper arms were pressurized for 5 minutes( Test group pressure = 200 mmHg ), and then breathed for 5 minutes. It was an ischemia-reperfusion cycle. Each training was performed for 5 consecutive cycles, 1 in the morning and 1 in the afternoon, 2 times / day, at least 5 days a week, for a total of 4 weeks.

  • Sham Ischemic Preconditioning Device

    Device

    A sham training device that is identical in appearance, sound, and wear sensation to the experimental device. During the "pressure" phase, the cuff is inflated to a non-ischemic low pressure (60 mmHg) to mimic device operation. The treatment schedule (cycles, frequency, duration) is identical to the experimental arm.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: treatment groupExperimental treatment 1 intervention
Group B: control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sleep efficiency as measured by polysomnography

Sleep efficiency is calculated as (total sleep time / total time in bed) × 100%, assessed by overnight polysomnography. Higher percentage indicates better sleep efficiency.

Time frame
4 weeks
2

Insomnia Severity Index (ISI) total score

The Insomnia Severity Index is a 7-item self-report questionnaire assessing perceived insomnia severity. Each item is rated on a 0-4 scale, yielding a total score ranging from 0 to 28. Higher scores indicate more severe insomnia.

Time frame
4 weeks

Secondary outcomes

1

Pittsburgh Sleep Quality Index (PSQI) global score

he PSQI is a self-rated questionnaire assessing sleep quality over the past month. It contains 19 items generating 7 component scores, which are summed to yield a global score ranging from 0 to 21. Higher scores indicate worse sleep quality.

Time frame
4 weeks, 3 months, 6 months
2

Change from baseline in sleep onset latency (SOL) as measured by polysomnography

Sleep onset latency is defined as the time from lights out to the first epoch of any stage of sustained sleep (in minutes), measured by overnight polysomnography. The change from baseline to post-intervention will be calculated. Lower values indicate faster sleep onset.

Time frame
4 weeks
3

Change from baseline in total sleep time (TST) as measured by polysomnography

Total sleep time is the total duration of all sleep stages (N1, N2, N3, REM) during the recording night (in minutes), measured by overnight polysomnography. The change from baseline to post-intervention will be calculated. Higher values indicate longer sleep duration.

Time frame
4 weeks
4

Change from baseline in percentage of stage N1 sleep (N1%) as measured by polysomnography

Stage N1 sleep is the transitional, lightest stage of non-rapid eye movement (NREM) sleep. N1% is calculated as (total time in N1 sleep / total sleep time) × 100%, derived from overnight polysomnography. The change from baseline to post-intervention will be calculated.

Time frame
4 weeks

Other outcomes

Locations

This trial has no locations.

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