NCT05594212

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

October 21, 2022

Last Update Submit

October 21, 2022

Conditions

Keywords

abdominal breathingobstructive sleep apneadepressionanxietyheart rate variability

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Beck anxiety inventory

    Pre-test

  • Beck anxiety inventory

    Post-test at week 4

  • Beck anxiety inventory

    Post-test at week 8

Other Outcomes (3)

  • Heart rate variability

    Pre-test

  • Heart rate variability

    Post-test at week 4

  • Heart rate variability

    Post-test at week 8

Study Arms (2)

The effectiveness of receiving abdominal breathing training

EXPERIMENTAL

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

The effectiveness of not receiving abdominal breathing training

NO INTERVENTION

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.

Interventions

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 receiving abdominal breathing training

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuan-Yi Huang

Taipei, Peitou, 11219, Taiwan

Location

Related 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.

    PMID: 33269134BACKGROUND
  • 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.

    PMID: 22298252BACKGROUND
  • Bollig SM. Encouraging CPAP adherence: it is everyone's job. Respir Care. 2010 Sep;55(9):1230-9.

    PMID: 20800003BACKGROUND
  • 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.

    PMID: 30083485BACKGROUND
  • 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.

    PMID: 27553981BACKGROUND
  • 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.

    PMID: 27568340BACKGROUND
  • 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.

    PMID: 25793429BACKGROUND
  • 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.

    PMID: 30245619BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, ObstructiveDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Xuan-Yi Huang, DNSc

    National Taipei University of Nursing and Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, DNSc, Professor

Study Record Dates

First Submitted

October 21, 2022

First Posted

October 26, 2022

Study Start

January 25, 2022

Primary Completion

August 5, 2022

Study Completion

September 24, 2022

Last Updated

October 26, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations