Clinical trial NCT04143022: Evaluation of the Effects of Acupuncture Press Needle in Mild to Moderate Obstructive Sleep Apnea Patients
Official title: Evaluation of the Effects of Acupuncture Press Needle in Mild to Moderate Obstructive Sleep Apnea Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Apnea, Obstructive Sleep
Snoring
Keywords: acupuncture press needle
obstructive sleep apnea
polysomnography
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 40 eligible participants diagnosed as mild to moderate OSA will be enrolled and randomly allocated to group A and group B. 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. The primary outcomes include the apnea-hypopnea index (AHI), snore time, snore index assessed by polysomnography, snore sound assessed by SnoreLab (snore recording and analysis application), and secondary outcome includes snore outcome survey questionnaire (SOS).
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Apnea-Hypopnea Index (AHI) measured by polysomnography (PSG)
timeFrame: change from baseline AHI at 4 weeks and 10 weeks post-treatment
measure: Change of Snore Index (SI) measured by polysomnography (PSG)
timeFrame: change from baseline SI at 4 weeks and 10 weeks post-treatment
Secondary outcomes:
measure: Change of snore outcome survey questionnaire (SOS)
timeFrame: change from baseline Snore outcome survey questionnaire (SOS) at 4 weeks and 10 weeks post-treatment
measure: Change of anti-snore solution record (apnea counts and snore counts)
timeFrame: This application is applied for every night to record apnea counts and snore counts before treatment and last for 10 weeks.
measure: Change of anti-snore solution record (snore volume)
timeFrame: This application is applied for every night to record snore volume before treatment and last for 10 weeks.
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Keelung Chang Gung Memorial Hospital
Study officials:
References: