Abdominal Breathing for Depression, Anxiety, Heart Rate Variability in Obstructive Sleep Apnea Patients

October 21, 2022 updated by: Xuan-Yi Huang, National Taipei University of Nursing and Health Sciences

The Effect of Abdominal Breathing on Improving of Depression, Anxiety, and Heart Rate Variability in Obstructive Sleep Apnea Patients With Depressive Symptoms

The research topic is to explore the effectiveness of abdominal breathing on improving of depression, anxiety, and heart rate variability in obstructive sleep apnea patients with depressive symptoms. This study method adopts an experimental research design and divided into experimental group and control group by random sampling. Experimental group receives abdominal breathing training, whereas control group without receiving abdominal breathing training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obstructive Sleep Apnea (OSA) is a common chronic disease with frequent comorbidity of depression. When we use sedatives, antidepressants or hypnotics for the treatment of depression, these drugs may worsen symptoms of OSA leading to aggravation of original depressed moods. Therefore, the research topic is to explore the effectiveness of abdominal breathing on improving of depression, anxiety, and heart rate variability among obstructive sleep apnea patients with depressive symptoms. This study method adopts an experimental research design and divided into experimental group and control group by random sampling. Experimental group receives abdominal breathing training, whereas control group without receiving abdominal breathing training. The research is conducted with experimental and control groups. The effectiveness assessment will use the Beck Depression Inventory (BDI) Beck Anxiety Inventory (BAI) and check the heart rate variability (HRV). Both groups received the pre-test before the abdominal breathing training. The post-test was carried out at the fourth and eighth weeks of training. The experimental group is given abdominal breathing training for a total of 8 weeks, with the training in the hospital once a week, 15 minutes for each time, in combination with self-training at home under videos guidance for 10 minutes per day (10 minutes, for one time or several times accumulated) .The expected result is through abdominal breathing, the depression, anxiety, and heart rate variability of OSA patients with depressive symptoms can improve, and even with less use of medication.

Study Type

Interventional

Enrollment (Actual)

70

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 Locations

  • Taiwan
    • Peitou
      • Taipei, Peitou, Taiwan, 11219
        • Xuan-Yi Huang

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

16 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 20-64 years old.
  • Be able to communicate with Chinese and Taiwanese, and who can express themselves without barriers.
  • A person who is clearly conscious and can perform breathing exercises autonomously.
  • Patients diagnosed with obstructive sleep apnea (AHI≧5) according to polysomnography and depression score ≧14 points measured by Beck Depression Inventory-II (Chinese version).

Exclusion Criteria:

  • Patients with COPD.
  • Patients with suicidal ideation.
  • Obstructive sleep apnea AHI≧60.
  • Those who have learned abdominal breathing.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The effectiveness of receiving abdominal breathing training
The effectiveness of receiving abdominal breathing training Training for 8 weeks (1 time a week, 15 minutes each time). Performed one-on-one by a trainer in a sleep center. At home, you can use the abdominal breathing training video to train yourself (10 minutes a day, can be divided into 10 minutes), and you need to fill in the abdominal breathing training log.
Behavioral: Abdominal breathing training
In the sleep center, it is carried out in a one-on-one manner by the trainer. At home, self-training through abdominal breathing training videos (10 minutes per day, you can accumulate up to 10 minutes in divided doses)
No Intervention: The effectiveness of not receiving abdominal breathing training
The effectiveness of not receiving abdominal breathing training The trainer does not provide abdominal breathing training, does not perform abdominal breathing exercises at home, and does not need to fill in abdominal breathing training logs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory-II
Time Frame: Pre-test
The total items of Beck Depression Inventory-II are 21. The score of each item is from 0-3. The score 0-13 is the normal range, 14-19 is the mild depression, 20-28 is the moderate depression, and 29-63 is the severe depression.
Pre-test
Beck Depression Inventory-II
Time Frame: Post-test at week 4
The total items of Beck Depression Inventory-II are 21. The score of each item is from 0-3. The score 0-13 is the normal range, 14-19 is the mild depression, 20-28 is the moderate depression, and 29-63 is the severe depression.
Post-test at week 4
Beck Depression Inventory-II
Time Frame: Post-test at week 8
The total items of Beck Depression Inventory-II are 21. The score of each item is from 0-3. The score 0-13 is the normal range, 14-19 is the mild depression, 20-28 is the moderate depression, and 29-63 is the severe depression.
Post-test at week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck anxiety inventory
Time Frame: Pre-test
The total items of Beck anxiety inventory are 21. The score of each item is from 0-3. The score 0-7 is the least mild anxiety, 8-15 is the mild anxiety, 16-25 is the moderate anxiety, and 26-63 is the severe anxiety.
Pre-test
Beck anxiety inventory
Time Frame: Post-test at week 4
The total items of Beck anxiety inventory are 21. The score of each item is from 0-3. The score 0-7 is the least mild anxiety, 8-15 is the mild anxiety, 16-25 is the moderate anxiety, and 26-63 is the severe anxiety.
Post-test at week 4
Beck anxiety inventory
Time Frame: Post-test at week 8
The total items of Beck anxiety inventory are 21. The score of each item is from 0-3. The score 0-7 is the least mild anxiety, 8-15 is the mild anxiety, 16-25 is the moderate anxiety, and 26-63 is the severe anxiety
Post-test at week 8

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability
Time Frame: Pre-test
Changes in heart rate variability measured by TS-0411
Pre-test
Heart rate variability
Time Frame: Post-test at week 4
Changes in heart rate variability measured by TS-0411
Post-test at week 4
Heart rate variability
Time Frame: Post-test at week 8
Changes in heart rate variability measured by TS-0411
Post-test at week 8

Collaborators and Investigators

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

Sponsor

National Taipei University of Nursing and Health Sciences

Collaborators

Cheng-Hsin General Hospital

Investigators

  • Principal Investigator: Xuan-Yi Huang, DNSc, National Taipei University of Nursing and Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 25, 2022

Primary Completion (Actual)

August 5, 2022

Study Completion (Actual)

September 24, 2022

Study Registration Dates

First Submitted

October 21, 2022

First Submitted That Met QC Criteria

October 21, 2022

First Posted (Actual)

October 26, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 21, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (879)110A-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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