Obstructive Sleep ApneaNCT05594212
Abdominal Breathing for Depression, Anxiety, Heart Rate Variability in Obstructive Sleep Apnea Patients
A study testing Abdominal breathing training in people with Obstructive Sleep Apnea, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Abdominal breathing training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Jan 2022to 24 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- Patients with COPD.
- Patients with suicidal ideation.
- Obstructive sleep apnea AHI≧60.
- Those who have learned abdominal breathing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Abdominal breathing training
- Keywords
- abdominal breathing, obstructive sleep apnea, depression, anxiety, heart rate variability
- Medical subject headings
- Sleep Apnea, Obstructive, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal breathing trainingBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Post-test at week 8
Secondary outcomes (3)
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.
Measured: Pre-test
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.
Measured: Post-test at week 4
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
Measured: Post-test at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start25 Jan 2022
- Primary completion5 Aug 2022
- Study completion24 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Cheng-Hsin General Hospital
- Responsible party
- Principal investigator, Xuan-Yi Huang, National Taipei University of Nursing and Health Sciences
- Investigators
- Xuan-Yi Huang, DNSc, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594212
- Sponsor's protocol ID
- (879)110A-25
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33269134Asghari 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.
PubMed 22298252Bollig SM. Encouraging CPAP adherence: it is everyone's job. Respir Care. 2010 Sep;55(9):1230-9.
PubMed 20800003Bordoni 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.
PubMed 30083485Chen 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.
PubMed 27553981Senaratna 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.
PubMed 27568340Tsai 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.
PubMed 25793429Zaccaro 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.
PubMed 30245619
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Breathing on Improving of Depression, Anxiety, and Heart Rate Variability in Obstructive Sleep Apnea Patients With Depressive Symptoms
- ClinicalTrials.gov ID
- NCT05594212
- Acronym / sponsor ID
- (879)110A-25
- Conditions
- Obstructive Sleep Apnea
- Keywords
- abdominal breathing, obstructive sleep apnea, depression, anxiety, heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Cheng-Hsin General Hospital
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 24 Sep 2022 (actual)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| The effectiveness of receiving abdominal breathing training | Experimental | Behavioral: Abdominal breathing trainingThe 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 | 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. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- Patients with COPD.
- Patients with suicidal ideation.
- Obstructive sleep apnea AHI≧60.
- Those who have learned abdominal breathing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal breathing trainingIn 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) | Behavioural | The effectiveness of receiving abdominal breathing training |
Primary outcome
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.
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.
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.
3 secondary outcomes
Beck anxiety inventory
Time frame: Pre-test
Beck anxiety inventory
Time frame: Post-test at week 4
Beck anxiety inventory
Time frame: Post-test at week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Background: PubMed 33269134Akberzie 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.
- Background: PubMed 22298252Asghari 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.
- Background: PubMed 20800003Bollig SM. Encouraging CPAP adherence: it is everyone's job. Respir Care. 2010 Sep;55(9):1230-9.
- Background: PubMed 30083485Bordoni 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.
- Background: PubMed 27553981Chen 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.
- Background: PubMed 27568340Senaratna 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.
- Background: PubMed 25793429Tsai 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.
- Background: PubMed 30245619Zaccaro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuan-Yi Huang, DNSc principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal breathing training in people with Obstructive Sleep Apnea, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory-II (time frame: Pre-test). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05594212, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.