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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Abdominal breathing training
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring abdominal breathing, obstructive sleep apnea, depression, anxiety, heart rate variability

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Xuan-Yi Huang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The effectiveness of receiving abdominal breathing training

The effectiveness of not receiving abdominal breathing training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Beck Depression Inventory-II
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.
Beck Depression Inventory-II
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.
Beck Depression Inventory-II
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.

Secondary Outcome Measures

Beck anxiety inventory
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.
Beck anxiety inventory
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.
Beck anxiety inventory
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

Full Information

First Posted
October 21, 2022
Last Updated
October 21, 2022
Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Cheng-Hsin General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05594212
Brief Title
Abdominal Breathing for Depression, Anxiety, Heart Rate Variability in Obstructive Sleep Apnea Patients
Official Title
The Effect of Abdominal Breathing on Improving of Depression, Anxiety, and Heart Rate Variability in Obstructive Sleep Apnea Patients With Depressive Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
August 5, 2022 (Actual)
Study Completion Date
September 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Cheng-Hsin General Hospital

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
abdominal breathing, obstructive sleep apnea, depression, anxiety, heart rate variability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The effectiveness of receiving abdominal breathing training
Arm Type
Experimental
Arm Description
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.
Arm Title
The effectiveness of not receiving abdominal breathing training
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Abdominal breathing training
Intervention Description
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)
Primary Outcome Measure Information:
Title
Beck Depression Inventory-II
Description
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.
Time Frame
Pre-test
Title
Beck Depression Inventory-II
Description
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.
Time Frame
Post-test at week 4
Title
Beck Depression Inventory-II
Description
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.
Time Frame
Post-test at week 8
Secondary Outcome Measure Information:
Title
Beck anxiety inventory
Description
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.
Time Frame
Pre-test
Title
Beck anxiety inventory
Description
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.
Time Frame
Post-test at week 4
Title
Beck anxiety inventory
Description
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
Time Frame
Post-test at week 8
Other Pre-specified Outcome Measures:
Title
Heart rate variability
Description
Changes in heart rate variability measured by TS-0411
Time Frame
Pre-test
Title
Heart rate variability
Description
Changes in heart rate variability measured by TS-0411
Time Frame
Post-test at week 4
Title
Heart rate variability
Description
Changes in heart rate variability measured by TS-0411
Time Frame
Post-test at week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuan-Yi Huang, DNSc
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuan-Yi Huang
City
Taipei
State/Province
Peitou
ZIP/Postal Code
11219
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33269134
Citation
Akberzie W, Hesselbacher S, Aiyer I, Surani S, Surani ZS. The Prevalence of Anxiety and Depression Symptoms in Obstructive Sleep Apnea. Cureus. 2020 Oct 27;12(10):e11203. doi: 10.7759/cureus.11203.
Results Reference
background
PubMed Identifier
22298252
Citation
Asghari A, Mohammadi F, Kamrava SK, Tavakoli S, Farhadi M. Severity of depression and anxiety in obstructive sleep apnea syndrome. Eur Arch Otorhinolaryngol. 2012 Dec;269(12):2549-53. doi: 10.1007/s00405-012-1942-6.
Results Reference
background
PubMed Identifier
20800003
Citation
Bollig SM. Encouraging CPAP adherence: it is everyone's job. Respir Care. 2010 Sep;55(9):1230-9.
Results Reference
background
PubMed Identifier
30083485
Citation
Bordoni B, Purgol S, Bizzarri A, Modica M, Morabito B. The Influence of Breathing on the Central Nervous System. Cureus. 2018 Jun 1;10(6):e2724. doi: 10.7759/cureus.2724.
Results Reference
background
PubMed Identifier
27553981
Citation
Chen YF, Huang XY, Chien CH, Cheng JF. The Effectiveness of Diaphragmatic Breathing Relaxation Training for Reducing Anxiety. Perspect Psychiatr Care. 2017 Oct;53(4):329-336. doi: 10.1111/ppc.12184. Epub 2016 Aug 23.
Results Reference
background
PubMed Identifier
27568340
Citation
Senaratna CV, Perret JL, Lodge CJ, Lowe AJ, Campbell BE, Matheson MC, Hamilton GS, Dharmage SC. Prevalence of obstructive sleep apnea in the general population: A systematic review. Sleep Med Rev. 2017 Aug;34:70-81. doi: 10.1016/j.smrv.2016.07.002. Epub 2016 Jul 18.
Results Reference
background
PubMed Identifier
25793429
Citation
Tsai SH, Wang MY, Miao NF, Chian PC, Chen TH, Tsai PS. CE: original research: The efficacy of a nurse-led breathing training program in reducing depressive symptoms in patients on hemodialysis: a randomized controlled trial. Am J Nurs. 2015 Apr;115(4):24-32; quiz 33, 42. doi: 10.1097/01.NAJ.0000463023.48226.16.
Results Reference
background
PubMed Identifier
30245619
Citation
Zaccaro A, Piarulli A, Laurino M, Garbella E, Menicucci D, Neri B, Gemignani A. How Breath-Control Can Change Your Life: A Systematic Review on Psycho-Physiological Correlates of Slow Breathing. Front Hum Neurosci. 2018 Sep 7;12:353. doi: 10.3389/fnhum.2018.00353. eCollection 2018.
Results Reference
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Abdominal Breathing for Depression, Anxiety, Heart Rate Variability in Obstructive Sleep Apnea Patients

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