Clinical trial NCT05135611: The Efficacy of the 4-channel Sequential NMES for the Treatment of Sleep Apnea
Official title: The Efficacy of the 4-channel Sequential NMES for the Treatment of Sleep Apnea, Single-center Prospective, Open Level, Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep Apnea
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 11
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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 -

Exclusion Criteria:

1. In case of refusal of inspection
2. Patients who do not agree
3. When instructions cannot be performed due to dementia, mental illness, etc.
4. Patients with sleep apnea due to respiratory failure or cervical spine surgery
5. In case of central nervous system abnormalities such as stroke
6. Pregnant and lactating women
7. Patients who cannot apply the electrical stimulation treatment device due to allergy to electrical stimulation pad (allergic reaction to chemical substances such as silicone, polypropylene, polyethylene, etc.), hypersensitivity reaction, etc.
8. Patients with severe regurgitation during electrical stimulation application
9. Others who have comorbidities (e.g., epilepsy, malignant tumors, severe renal/liver/pulmonary diseases, blood coagulation abnormalities, use of anticoagulants, phlebitis, thermophlebitis, etc.)
10. Those who are judged by other researchers to be unsuitable for this clinical trial (e.g., patients with infectious diseases, those who have inflammation or wounds on the skin at the site of electrical stimulation, and those who believe that electrical stimulation can cause abnormalities in the body regardless of disease) judged person)
11. Those who have been diagnosed with a disease that cannot be stimulated

    i. In patients with peripheral neuropathy (ex. Guillain-Barré syndrome), the electric stimulator does not induce muscle contraction, so it is ineffective.

    ii. Patients with congenital myopathy and amyotrophic lateral sclerosis do not receive help because muscle contraction is not induced.
12. Patients with sleep apnea due to pharyngeal muscle weakness or abnormal muscle contraction pattern
13. Persons with pacemakers and other internal electrical stimulators
14. Patients with a history of surgery in the area where the medical device is applied, or in the upper respiratory tract or surrounding area
15. Structural diseases such as 'tonsil hypertrophy' and 'soft palate' that can cause 'obstructive sleep apnea' (examined by physical examination)

Primary outcomes:
measure: The difference value of polysomnography before and after treatment
timeFrame: After 8±2 weeks of treatment at home, it is performed within 2 weeks of the end of treatment.
Secondary outcomes:
measure: Sleep satisfaction and discomfort
timeFrame: After 8±2 weeks of treatment at home, it is performed within 2 weeks of the end of treatment.
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: InYoung Yoon, M.D, PhD
role: STUDY_DIRECTOR
References: