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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05594212
• Other study ID #: (879)110A-25
• Status: Completed
• Phase: N/A
• Start date: January 25, 2022
• Est. completion date: September 24, 2022

Study information

• Verified date: October 2022
• Source: National Taipei University of Nursing and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 24, 2022
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Depression
• Obstructive Sleep Apnea
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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)

Locations

Country	Name	City	State
Taiwan	Xuan-Yi Huang	Taipei	Peitou

Sponsors (2)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences	Cheng-Hsin General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (8)

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. — View 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. — View Citation

Bollig SM. Encouraging CPAP adherence: it is everyone's job. Respir Care. 2010 Sep;55(9):1230-9. Review. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart rate variability	Changes in heart rate variability measured by TS-0411	Pre-test
Other	Heart rate variability	Changes in heart rate variability measured by TS-0411	Post-test at week 4
Other	Heart rate variability	Changes in heart rate variability measured by TS-0411	Post-test at week 8
Primary	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.	Pre-test
Primary	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.	Post-test at week 4
Primary	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.	Post-test at week 8
Secondary	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.	Pre-test
Secondary	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.	Post-test at week 4
Secondary	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	Post-test at week 8