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

Primary Purpose

Sleep Apnea

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

4 channel Electrical Stimulation Device

About this trial

This is an interventional supportive care trial for Sleep Apnea

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adult males and females between the ages of 19 and 60 who do not fall under the exclusion criteria as study subjects
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 -

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

4-channel Sequential NMES

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sleep satisfaction and discomfort

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.

Full Information

NCT ID

NCT05135611

First Posted

November 24, 2021

Last Updated

November 28, 2022

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05135611

Brief Title

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

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 5, 2022 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

4-channel Sequential NMES

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

4 channel Electrical Stimulation Device

Intervention Description

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.

Primary Outcome Measure Information:

Title

The difference value of polysomnography before and after treatment

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Sleep satisfaction and discomfort

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult males and females between the ages of 19 and 60 who do not fall under the exclusion criteria as study subjects 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 - Exclusion Criteria: 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. ii. Patients with congenital myopathy and amyotrophic lateral sclerosis do not receive help because muscle contraction is not induced. Patients with sleep apnea due to pharyngeal muscle weakness or abnormal muscle contraction pattern Persons with pacemakers and other internal electrical stimulators Patients with a history of surgery in the area where the medical device is applied, or in the upper respiratory tract or surrounding area Structural diseases such as 'tonsil hypertrophy' and 'soft palate' that can cause 'obstructive sleep apnea' (examined by physical examination)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Juseok Ru, M.D, PhD

Phone

+82-31-787-7739

jseok337@snu.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Seungwo Lee, CRA

Phone

+82-5181-8066

kkdg1040@naver.com

Facility Information:

Facility Name

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

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

463-707

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juseok Ryu, M.D, PhD

Phone

+82-31-787-7739

jseok337@snu.ac.kr

First Name & Middle Initial & Last Name & Degree

Seungwo Lee, CRA

Phone

+82-5181-8066

kkdg1040@naver.com

12. IPD Sharing Statement

Learn more about this trial

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

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