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

NCT05135611 | Active Not Recruiting

• 1 other identifier: E-2112-726-001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• The difference value of polysomnography before and after treatment

  The index for primary efficacy evaluation is the apnea hypopnea index (AHI) calculated based on polysomnography.

  After 8±2 weeks of treatment at home, it is performed within 2 weeks of the end of treatment.

Secondary Outcomes (1)

• Sleep satisfaction and discomfort

  After 8±2 weeks of treatment at home, it is performed within 2 weeks of the end of treatment.

Study Arms (1)

4-channel Sequential NMES

EXPERIMENTAL

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.

Device: 4 channel Electrical Stimulation Device

Interventions

4 channel Electrical Stimulation Device 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.

4-channel Sequential NMES

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Patients with obstructive sleep apnea syndrome confirmed by polysomnography
• Those who voluntarily consented to the clinical trial
• Patients with sleep apnea with moderate or higher apnea hypopnea -
• In case of refusal of inspection
• Patients who do not agree
• When instructions cannot be performed due to dementia, mental illness, etc.
• Patients with sleep apnea due to respiratory failure or cervical spine surgery
• In case of central nervous system abnormalities such as stroke
• Pregnant and lactating women
• 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.
• Patients with severe regurgitation during electrical stimulation application
• Others who have comorbidities (e.g., epilepsy, malignant tumors, severe renal/liver/pulmonary diseases, blood coagulation abnormalities, use of anticoagulants, phlebitis, thermophlebitis, etc.)
• 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)
• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

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

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• InYoung Yoon, M.D, PhD

  Seoul National University Bundang Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: November 26, 2021
• Study Start: July 5, 2022
• Primary Completion: October 14, 2022
• Study Completion: June 30, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

KR (1)