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Clinical effectiveness of wearable respiratory device for risk factor management of cerebrovascular disease

Not Applicable
Completed
Conditions
Diseases of the circulatory system
Registration Number
KCT0008133
Lead Sponsor
Jeonbuk National University Hospital
Brief Summary

A study comparing the sleep and clinical outcomes between normal and stroke patient groups found significant differences. The total sleep time (TST) for the normal group was 465.33±24.60 minutes, while for the stroke patient group, it was significantly shorter at 305.46±192.75 minutes (p=0.001). The total apnea time (TAT) was 25.90±27.41 minutes for the normal group and 7.95±13.71 minutes for the stroke group, showing a shorter duration in the stroke patients (p=0.03). Snoring frequency was higher in the normal group (46.20±59.10 times) compared to the stroke group (16.63±26.02 times), but this difference was not statistically significant (p=0.086). Apnea frequency was also lower in the stroke group (24.50±38.07 times) compared to the normal group (84.80±90.01 times) (p=0.025). In terms of clinical data, stroke patients were older (41.87±21.20 vs. 56.06±10.52, p=0.029) and had higher incidences of hypertension (3 vs. 10, p=0.036), diabetes (2 vs. 11, p=0.005), and hyperlipidemia (4 vs. 12, p=0.047). Other hematological tests showed no significant differences between the groups. Average and standard deviation values of various sleep respiratory parameters for both groups were presented in Table 2, with changes at 30-minute intervals shown in Figure 4. Inspiratory duration (1.19±0.07 vs. 2.28±0.06 sec) and expiratory duration (1.88±0.05 vs. 2.10±0.05 sec) were longer in the stroke group. Snoring duration (46.97±15.77 vs. 22.67±10.66 sec) and apnea duration (46.39±16.64 vs. 7.03±4.36 sec) were shorter in the stroke group. Figure 4 also showed that both snoring and apnea durations had greater variability in the normal group compared to the stroke group.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
42
Inclusion Criteria

Men and women aged 20 years or older who visited the hospital for diagnosis and treatment of cardiovascular disease, who understood the participation in the study and gave written consent to it

Exclusion Criteria

1) Those with existing serious psychiatric disorders such as major schizophrenia and bipolar disorder
2) Those with untreated serious medical or surgical diseases
3) Those who are judged inappropriate to participate in this clinical trial according to the judgment of other researchers

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Snoring and breathing rate during sleep, number and duration of snoring/apnea/hypopnea events
Secondary Outcome Measures
NameTimeMethod
classification of REM sleep and sleep stages 3-4
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