Evaluation of the Effects of Acupuncture Press Needle in Mild to Moderate Obstructive Sleep Apnea Patients
1 other identifier
interventional
40
1 country
1
Brief Summary
The aim of this study is to investigate the effects of acupuncture press needle in mild to moderate obstructive sleep apnea patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2019
CompletedStudy Start
First participant enrolled
October 23, 2019
CompletedFirst Posted
Study publicly available on registry
October 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2020
CompletedOctober 29, 2019
January 1, 2019
10 months
March 20, 2019
October 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (3)
Change of snore outcome survey questionnaire (SOS)
change from baseline Snore outcome survey questionnaire (SOS) at 4 weeks and 10 weeks post-treatment
Change of anti-snore solution record (apnea counts and snore counts)
This application is applied for every night to record apnea counts and snore counts before treatment and last for 10 weeks.
Change of anti-snore solution record (snore volume)
This application is applied for every night to record snore volume before treatment and last for 10 weeks.
Study Arms (2)
group A (acupuncture press needle)
ACTIVE COMPARATORGroup 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 B (acupuncture press needle)
ACTIVE COMPARATORGroup 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Willing to sign inform consent with aged more than 20 years old
- Mild to moderate OSA, AHI \< 30
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Keelung Chang Gung Memorial Hospital
Keelung, 20401, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2019
First Posted
October 29, 2019
Study Start
October 23, 2019
Primary Completion
August 31, 2020
Study Completion
December 22, 2020
Last Updated
October 29, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share
1. There will be a research number representing the identity. This number will not display the name, identification number, and address. 2. For the results and diagnosis of the visit, the research host will maintain a confidential attitude and carefully maintain the privacy. If research results are published, the identity will remain confidential. 3. Please also understand that if the participant signs the consent form, the participant agrees that the visit record can be directly reviewed by the monitor, auditor, research ethics committee and the competent authority to ensure that the research process and data comply with relevant laws and regulations. These people also promise not to violate the confidentiality of your identity.