Sleep Apnea
Conditions
Brief summary
In the treatment of obstructive sleep apnea, by using sequential 4-channel electrical stimulation treatment, unlike conventional positive pressure devices, it can be done more effectively by improving the strength of the biceps and soft palate, which are the causes of sleep apnea. thought.
Detailed description
Design: Prospective study Inclusion criteria of patient group: Patients aged 19 to 60 years diagnosed with moderate to severe obstructive sleep apnea(n=11) Main outcome measures: AHI (apnea-hypoapnea index), Oxygen saturation lowering variables (minimum oxygen saturation, oxygen saturation time less than 90% (%), oxygen desaturation index (ODI) , REM sleep time and ratio of each). Satisfaction with sleep and discomfort of electrical stimulation treatment before and after treatment were evaluated on the Likert scale. Evaluate the state of health before and after electrical stimulation treatment through EQ-5D-5L.
Interventions
electrical stimulation at muscles which related with sleep apnea,. 4-channel NMES is the protocol that provides sequential electrical stimulation to Rt. suprahyoid m (channel 1), Lt.suprahyoid m (channel 2), bilateral thyrohyoid m (channel 3), and biltateral sternothyroid m (channel 4). At this time, channels 1 and 2 start to contract first and stimulate for 1200ms, and channel 3 starts stimulation 150ms after channels 1 and 2, and applies stimulation for 1050ms. Channel 4 starts stimulation 250ms after stimulation of channels 1 and 2 and stimulates it for 950 ms.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adult males and females between the ages of 19 and 60 who do not fall under the
Exclusion criteria
as study subjects 2. Patients with obstructive sleep apnea syndrome confirmed by polysomnography 3. Those who voluntarily consented to the clinical trial 4. Patients with sleep apnea with moderate or higher apnea hypopnea -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference value of polysomnography before and after treatment | After 8±2 weeks of treatment at home, it is performed within 2 weeks of the end of treatment. | The index for primary efficacy evaluation is the apnea hypopnea index (AHI) calculated based on polysomnography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep satisfaction and discomfort | After 8±2 weeks of treatment at home, it is performed within 2 weeks of the end of treatment. | Satisfaction and discomfort during sleep before and after treatment are evaluated using the Likert Scale scale and verified using the EQ-5D-DL questionnaire that evaluates each individual's health status in a self-written method. |
Countries
South Korea
Outcome results
None listed