search
Back to results

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

Primary Purpose

Apnea, Obstructive Sleep, Snoring

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture press needle
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apnea, Obstructive Sleep focused on measuring acupuncture press needle, obstructive sleep apnea, polysomnography

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keelung Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group A (acupuncture press needle)

group B (acupuncture press needle)

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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 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.

Secondary Outcome Measures

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 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.
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.

Full Information

First Posted
March 20, 2019
Last Updated
October 27, 2019
Sponsor
Chang Gung Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04143022
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 23, 2019 (Anticipated)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
December 22, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea, Obstructive Sleep, Snoring
Keywords
acupuncture press needle, obstructive sleep apnea, polysomnography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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).
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A (acupuncture press needle)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
group B (acupuncture press needle)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
acupuncture press needle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Apnea-Hypopnea Index (AHI) measured by polysomnography (PSG)
Description
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.
Time Frame
change from baseline AHI at 4 weeks and 10 weeks post-treatment
Title
Change of Snore Index (SI) measured by polysomnography (PSG)
Description
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.
Time Frame
change from baseline SI at 4 weeks and 10 weeks post-treatment
Secondary Outcome Measure Information:
Title
Change of snore outcome survey questionnaire (SOS)
Description
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.
Time Frame
change from baseline Snore outcome survey questionnaire (SOS) at 4 weeks and 10 weeks post-treatment
Title
Change of anti-snore solution record (apnea counts and snore counts)
Description
Anti-snore solution is one kind of smartphone application for recording sleep condition. Apnea counts and sleep counts can be detected by this software.
Time Frame
This application is applied for every night to record apnea counts and snore counts before treatment and last for 10 weeks.
Title
Change of anti-snore solution record (snore volume)
Description
Anti-snore solution is one kind of smartphone application for recording sleep condition. Snore volume (in dB) can be detected by this software.
Time Frame
This application is applied for every night to record snore volume before treatment and last for 10 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YUAN-CHIEH YEH, Doctor
Phone
24313131
Ext
2127
Email
b9005030@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
YI-HSIEN SHIAO, Doctor
Phone
24313131
Ext
2127
Email
vincentking44@gmail.com
Facility Information:
Facility Name
Keelung Chang Gung Memorial Hospital
City
Keelung
ZIP/Postal Code
20401
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There will be a research number representing the identity. This number will not display the name, identification number, and address. 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. 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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs