Sleep DisorderNCT05739773
Evaluation of the Effect of Combined Music on Sleep Disorder
A study testing five-element music therapy in people with Sleep Disorder, run by China Medical University, Taiwan at 1 site in Taiwan.
Trial summary
The results of this study will provide an affordable, safe and scientific treatment for patients with sleep disorders, so that patients can improve their sleep quality at home. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- five-element music therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Oct 2022to 11 Oct 2023
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sleep disorder
- PSQI score > 5
Who cannot join
- Using tranquilizers or taking drugs or foods (such as coffee or refreshing drinks)
- Severe cardiopulmonary disease (heart failure or cardiopulmonary failure) or cancer
- Kidney dialysis patients
- Patients with cardiac rhythm regulators or built-in hearing aids
- Pregnant women and women who are still breastfeeding
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Yueh-Ting Tsai
Taichung
Yueh-Ting Tsai, 0963675111, yuehting.tsai@gmail.com
About this study
Official title: Evaluation of the Effect of Five Elements Music Combined With Binaural Beat on Sleep Disorder
The results of this study will provide an affordable, safe and scientific treatment for patients with sleep disorders, so that patients can improve their sleep quality at home.
Read the detailed description
The population suffered from sleep disorders is raising year by year, it has increased much social costs and medical burdens, especially the spread of the COVID-19 epidemic has made it even worse recently. Although many studies in the past few years have found that the use of non-invasive music therapy (such as five-element music, music combined with binaural beats) can effectively improve sleep quality, however, there is a lack of rigorous study design and measurement tools (scientific instrument examination).
To explore the effects of short-term sleep quality in patients with sleep disorders after receiving five-element music therapy or binaural beats, and further explore the combination of the above two music therapies to verify its effectiveness in improving long-term sleep quality.
The first year study was a randomized single-blind trial. 60 patients with sleep disorders were randomly assigned to the five-element music group and binaural beats group for two consecutive nights treatment to verify their short-term effects and assess the differences between them; the second year study was a randomized controlled trial , 60 patients with sleep disorders were randomly assigned to the five-element music combined with binaural beats group and the control group for four-week follow-up treatment to verify their long-term results and evaluate the feasibility of home treatment. The main results were measured with meridian energy examination and polysomnography. Other secondary results include sleep-related questionnaires (including Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Berlin Questionnaire, Hospital Anxiety and Depression Scale).
- Conditions
- Sleep Disorder
- Being tested
- five-element music therapy
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
five-element music therapyOther
Also called binaural beats
music therapy
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | the five-element music group Receives: Other: five-element music therapy |
| Control | Placebo comparator | binaural beats group Receives: Other: five-element music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
polysomnography
Polysomnography refers to a systematic process used to collect physiologic parameters during sleep
Measured: two consecutive nights
change meridian energy
Meridian energy examination
Measured: two consecutive nights
Secondary outcomes (4)
Pittsburgh Sleep Quality Index
sleep-related questionnaire
Measured: two consecutive nights
Epworth Sleepiness Scale
sleep-related questionnaire
Measured: two consecutive nights
Berlin Questionnaire
sleep-related questionnaire
Measured: two consecutive nights
Hospital Anxiety and Depression Scale
sleep-related questionnaires
Measured: two consecutive nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start7 Oct 2022
- Primary completion11 Aug 2023 (estimated)
- Study completion11 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yueh-Ting Tsai, China Medical University, Taiwan
- Investigators
- Yueh-Ting Tsai, Principal investigator, China Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739773
- Sponsor's protocol ID
- P11001
- Other IDs
- CMUH110-REC1-170
- Status last verified
- Feb 2023
- First submitted
- 5 Nov 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Five Elements Music Combined With Binaural Beat on Sleep Disorder
- ClinicalTrials.gov ID
- NCT05739773
- Acronym / sponsor ID
- P11001
- Conditions
- Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University, TaiwanUniversity, hospital or other
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 11 Aug 2023 (estimated)
- Study completion
- 11 Oct 2023 (estimated)
- First posted
- 22 Feb 2023 (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 results of this study will provide an affordable, safe and scientific treatment for patients with sleep disorders, so that patients can improve their sleep quality at home.
Detailed description
The population suffered from sleep disorders is raising year by year, it has increased much social costs and medical burdens, especially the spread of the COVID-19 epidemic has made it even worse recently. Although many studies in the past few years have found that the use of non-invasive music therapy (such as five-element music, music combined with binaural beats) can effectively improve sleep quality, however, there is a lack of rigorous study design and measurement tools (scientific instrument examination).
To explore the effects of short-term sleep quality in patients with sleep disorders after receiving five-element music therapy or binaural beats, and further explore the combination of the above two music therapies to verify its effectiveness in improving long-term sleep quality.
The first year study was a randomized single-blind trial. 60 patients with sleep disorders were randomly assigned to the five-element music group and binaural beats group for two consecutive nights treatment to verify their short-term effects and assess the differences between them; the second year study was a randomized controlled trial , 60 patients with sleep disorders were randomly assigned to the five-element music combined with binaural beats group and the control group for four-week follow-up treatment to verify their long-term results and evaluate the feasibility of home treatment. The main results were measured with meridian energy examination and polysomnography. Other secondary results include sleep-related questionnaires (including Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Berlin Questionnaire, Hospital Anxiety and Depression Scale).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Other: five-element music therapythe five-element music group |
| Control | Placebo comparator | Other: five-element music therapybinaural beats group |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- sleep disorder
- PSQI score > 5
Key exclusion criteria (5 listed)
- Using tranquilizers or taking drugs or foods (such as coffee or refreshing drinks)
- Severe cardiopulmonary disease (heart failure or cardiopulmonary failure) or cancer
- Kidney dialysis patients
- Patients with cardiac rhythm regulators or built-in hearing aids
- Pregnant women and women who are still breastfeeding
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 |
|---|---|---|
| five-element music therapyAlso: binaural beatsmusic therapy | Other | Control, Study |
Primary outcome
polysomnography
Time frame: two consecutive nights
Polysomnography refers to a systematic process used to collect physiologic parameters during sleep
change meridian energy
Time frame: two consecutive nights
Meridian energy examination
4 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: two consecutive nights
Epworth Sleepiness Scale
Time frame: two consecutive nights
Berlin Questionnaire
Time frame: two consecutive nights
Hospital Anxiety and Depression Scale
Time frame: two consecutive nights
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- 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.
Yueh-Ting Tsai principal investigator
China Medical University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing five-element music therapy in people with Sleep Disorder, run by China Medical University, Taiwan 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Feb 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yueh-Ting Tsai (0963675111, yuehting.tsai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
polysomnography (time frame: two consecutive nights). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2023.