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

October 27, 2019 updated by: Chang Gung Memorial Hospital
The aim of this study is to investigate the effects of acupuncture press needle in mild to moderate obstructive sleep apnea patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Keelung, Taiwan, 20401
        • Keelung Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Apnea-Hypopnea Index (AHI) measured by polysomnography (PSG)
Time Frame: change from baseline AHI at 4 weeks and 10 weeks post-treatment
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)
Time Frame: change from baseline SI at 4 weeks and 10 weeks post-treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of snore outcome survey questionnaire (SOS)
Time Frame: change from baseline Snore outcome survey questionnaire (SOS) at 4 weeks and 10 weeks post-treatment
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
Change of anti-snore solution record (apnea counts and snore counts)
Time Frame: This application is applied for every night to record apnea counts and snore counts before treatment and last for 10 weeks.
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.
Change of anti-snore solution record (snore volume)
Time Frame: This application is applied for every night to record snore volume before treatment and last for 10 weeks.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 23, 2019

Primary Completion (Anticipated)

August 31, 2020

Study Completion (Anticipated)

December 22, 2020

Study Registration Dates

First Submitted

March 20, 2019

First Submitted That Met QC Criteria

October 27, 2019

First Posted (Actual)

October 29, 2019

Study Record Updates

Last Update Posted (Actual)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 27, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201801807A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

  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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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