Sleep ApneaNCT05135611
The Efficacy of the 4-channel Sequential NMES for the Treatment of Sleep Apnea
A study testing 4 channel Electrical Stimulation Device in people with Sleep Apnea, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- 4 channel Electrical Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jul 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 -
Who cannot join
- 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
Show all 17Show fewer
- 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
- In patients with peripheral neuropathy (ex. Guillain-Barré syndrome), the electric stimulator does not induce muscle contraction, so it is ineffective.
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: The Efficacy of the 4-channel Sequential NMES for the Treatment of Sleep Apnea, Single-center Prospective, Open Level, Pilot Study
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.
Read the 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
- Being tested
- 4 channel Electrical Stimulation Device
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 channel Electrical Stimulation DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 4 channel Electrical Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: After 8±2 weeks of treatment at home, it is performed within 2 weeks of the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start5 Jul 2022
- Primary completion14 Oct 2022
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Seok Ryu, Seoul National University Hospital
- Investigators
- InYoung Yoon, M.D, PhD, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135611
- Sponsor's protocol ID
- E-2112-726-001
- Status last verified
- Apr 2024
- First submitted
- 24 Nov 2021
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the 4-channel Sequential NMES for the Treatment of Sleep Apnea, Single-center Prospective, Open Level, Pilot Study
- ClinicalTrials.gov ID
- NCT05135611
- Acronym / sponsor ID
- E-2112-726-001
- Conditions
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4-channel Sequential NMES | Experimental | Device: 4 channel Electrical Stimulation DeviceAfter 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. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 -
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4 channel Electrical Stimulation Deviceelectrical 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. | Device | 4-channel Sequential NMES |
Primary outcome
The difference value of polysomnography before and after treatment
Time frame: 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.
1 secondary outcome
Sleep satisfaction and discomfort
Time frame: After 8±2 weeks of treatment at home, it is performed within 2 weeks of the end of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
Related trials for Sleep Apnea
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
InYoung Yoon, M.D, PhD study director
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 channel Electrical Stimulation Device in people with Sleep Apnea, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference value of polysomnography before and after treatment (time frame: After 8±2 weeks of treatment at home, it is performed within 2 weeks of the end of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.