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

NCT ID: NCT05135611

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-05
• Study Completion Date: 2024-06-30

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.

Conditions

Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

4-channel Sequential NMES

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.

Group Type: EXPERIMENTAL

4 channel Electrical Stimulation Device

Intervention Type: DEVICE

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.

Interventions

4 channel Electrical Stimulation Device

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.

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

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 -

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ju Seok Ryu

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

InYoung Yoon, M.D, PhD

Role: STUDY_DIRECTOR

Seoul National University Bundang Hospital

Locations

Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

E-2112-726-001

Identifier Type: -

Identifier Source: org_study_id