Evaluation of the Effects of Acupuncture Press Needle in Mild to Moderate Obstructive Sleep Apnea Patients

Snoring Clinical Trial

Official title:

Evaluation of the Effects of Acupuncture Press Needle in Mild to Moderate Obstructive Sleep Apnea Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04143022
• Other study ID #: 201801807A3
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 23, 2019
• Est. completion date: December 22, 2020

Study information

• Verified date: January 2019
• Source: Chang Gung Memorial Hospital
• Contact: YUAN-CHIEH YEH, Doctor
• Phone: 24313131
• Email: b9005030[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the effects of acupuncture press needle in mild to moderate obstructive sleep apnea patients.

Description:

Obstructive sleep apnea(OSA) is characterized by multiple episodes of upper airway collapse during sleep and considered as a major health issue worldwide due to comorbidity with obesity, hypertension, diabetes and more advanced cardiovascular diseases. The noisy sounds of snoring caused by OSA bother bed partner sleepless and lead to long-term health problems. Most patients do not tolerate nasal continuous positive airway pressure device, which is the gold standard treatment of OSA. Press needle is one kind of acupuncture which possesses more safety and convenient, few complications and prolonged period of treatment time compared to conventional acupuncture. To date, there is no study to evaluate the effects of press needle in treating OSA. The investigators hypothesize that press needle is effective with high acceptability among OSA patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 22, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Willing to sign inform consent with aged more than 20 years old

• Mild to moderate OSA, AHI < 30

Exclusion Criteria:

• Severe OSA, AHI > 30

• Significant lung disease

• Skeletal facial framework problems

• Central apnea

• Undergone oropharyngeal operations, continuous positive airway pressure or oral devices

• Taking hypnotic drugs

• Pregnancy or breast-feeding

• Receiving acupuncture in recent 2 weeks

Related Conditions & MeSH terms

• Apnea
• Apnea, Obstructive Sleep
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Snoring

Intervention

Device:
• acupuncture press needle
Press needle will be applied to acupoints at Jin's 3-tongue point ( EX-HN21 and the two extra channel points, 0.8 individual cun lateral to both sides of EX-HN21) and EX-HN25 in group A and at EX-CA1, EX-CA5 and EX-CA6 in group B. Each subject will start first course and receive the treatment 2 times a week for 4 weeks (8 times in total). Then, it takes 2-week washout period and make group A and group B crossover. Second course begins after 2-week washout period with the same treatment times as the first course.

Locations

Country	Name	City	State
Taiwan	Keelung Chang Gung Memorial Hospital	Keelung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Apnea-Hypopnea Index (AHI) measured by polysomnography (PSG)	PSG is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine. AHI is calculated by dividing the number of apnea events by the number of hours of sleep.	change from baseline AHI at 4 weeks and 10 weeks post-treatment
Primary	Change of Snore Index (SI) measured by polysomnography (PSG)	PSG is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine. SI is calculated by dividing the number of snore events by the number of hours of sleep.	change from baseline SI at 4 weeks and 10 weeks post-treatment
Secondary	Change of snore outcome survey questionnaire (SOS)	The questionnaire used for a patient-based measure for the full range of sleep-disordered breathing patients in whom snoring is a primary symptom, where the goal is to measure the snoring component of sleep-disordered breathing. Total scores are normalized on a scale from 0 to 100. Higher values indicates a better outcome.	change from baseline Snore outcome survey questionnaire (SOS) at 4 weeks and 10 weeks post-treatment
Secondary	Change of anti-snore solution record (apnea counts and snore counts)	Anti-snore solution is one kind of smartphone application for recording sleep condition. Apnea counts and sleep counts can be detected by this software.	This application is applied for every night to record apnea counts and snore counts before treatment and last for 10 weeks.
Secondary	Change of anti-snore solution record (snore volume)	Anti-snore solution is one kind of smartphone application for recording sleep condition. Snore volume (in dB) can be detected by this software.	This application is applied for every night to record snore volume before treatment and last for 10 weeks.