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

Sleep Apnea Clinical Trial

Official title:

The Efficacy of the 4-channel Sequential NMES for the Treatment of Sleep Apnea, Single-center Prospective, Open Level, Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05135611
• Other study ID #: E-2112-726-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 5, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: June 30, 2024
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	After 8±2 weeks of treatment at home, it is performed within 2 weeks of the end of treatment.