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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-23

Study Completion Date

2020-12-22

Brief Summary

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

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Detailed Description

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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.

Conditions

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Apnea, Obstructive Sleep Snoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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group A (acupuncture press needle)

Group A subjects first receive acupuncture press needle treatment at acupoint of Jin's 3-tongue point and EX-HN25. Then, it takes 2-week washout period. After washout period, subjects receive another course of treatment at acupoint of EX-CA1, EX-CA5 and EX-CA6. Each subject receive 2 times a week of treatment for 4 weeks (8 times in total) in each course.

Group Type ACTIVE_COMPARATOR

acupuncture press needle

Intervention Type DEVICE

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.

group B (acupuncture press needle)

Group B subjects first receive acupuncture press needle treatment at acupoint of EX-CA1, EX-CA5 and EX-CA6. Then, it takes 2-week washout period. After washout period, subjects receive another course of treatment at acupoint of Jin's 3-tongue point and EX-HN25. Each subject receive 2 times a week of treatment for 4 weeks (8 times in total) in each course.

Group Type ACTIVE_COMPARATOR

acupuncture press needle

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No