The Efficacy of the 4-channel Sequential NMES for the Treatment of Sleep Apnea

Not Applicable

Active, not recruiting

• Conditions: Sleep Apnea
• Interventions: Device: 4 channel Electrical Stimulation Device

• Registration Number: NCT05135611
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2021-11-24
• Study First Submitted QC: 2021-11-24
• Study First Posted: 2021-11-26
• Study Start: 2022-07-05
• Primary Completion: 2022-10-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 11

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4-channel Sequential NMES	4 channel Electrical Stimulation Device	After diagnosis of sleep apnea, the registered patient group receives sufficient explanations from the researcher and uses sequential 4-channel electrical stimulation therapy at home, 5 times a week, 60 minutes each, for 8±2 weeks. During 4-channel electrical stimulation treatment, study participants kept a treatment log including the number of applications, intensity (mA), and treatment time at home.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of