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

NCT ID: NCT05594212

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-25

Study Completion Date

2022-09-24

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Abdominal breathing training

Intervention Type BEHAVIORAL

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)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cheng-Hsin General Hospital

OTHER

Sponsor Role collaborator

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Xuan-Yi Huang

RN, DNSc, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xuan-Yi Huang, DNSc

Role: PRINCIPAL_INVESTIGATOR

National Taipei University of Nursing and Health Sciences

Locations

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Xuan-Yi Huang

Taipei, Peitou, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 33269134 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22298252 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 20800003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30083485 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27553981 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27568340 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25793429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30245619 (View on PubMed)

Other Identifiers

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(879)110A-25

Identifier Type: -

Identifier Source: org_study_id

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