Polycystic Ovary SyndromeNCT06009172
APA on Sleep Quality in Women With PCOS
A study testing Auricular point acupressure (APA) in people with Polycystic Ovary Syndrome, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
Women with polycystic ovary syndrome (PCOS) appear to have an increased frequency of sleep problems. The aim of this study was to explore the effect of auricular point acupressure (APA) pressure on sleep quality in women with PCOS. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Auricular point acupressure (APA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2022to 31 Jul 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Subjects were included if they
- were aged between 18-40 years old;
- met the clinical diagnostic criteria of Western and Chinese medicine for PCOS with sleep disorders;
- were evaluated by the Pittsburgh Sleep Quality Index Scale (PSQI) and had a score ≥ 7 points;
- did not participate in other clinical trials.
Subjects were excluded if they
- had a serious organic condition such as cardiovascular, cerebrovascular, liver, or kidney disease;
- had acute gynecological inflammation, gynecological tumors, or reproductive system malformations;
- had severe anxiety, depression, or other mental illnesses;
- were pregnant;
- had used sleeping and sedative drugs in the past month;
- were allergic to ear point tape;
- had local rupture of the skin at the selected ear point;
- refused to fill out questionnaires and sign informed consent forms.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology and Diabetes, the First Affiliated Hospital of Xiamen University, School of medicine, Xiamen university, Xiamen, China
Xiamen, Fujian, 361003
About this study
Official title: The Effect of Auricular Point Acupressure on Sleep Quality in Women With Polycystic Ovary Syndrome：A Randomized Controlled Trial
Women with polycystic ovary syndrome (PCOS) appear to have an increased frequency of sleep problems. The aim of this study was to explore the effect of auricular point acupressure (APA) pressure on sleep quality in women with PCOS.
Read the detailed description
Polycystic ovary syndrome (PCOS) is a prevalent disorder affecting 5-18% of reproductive-age women. In recent years, women with PCOS appear to have an increased frequency of sleep problems, and the prevalence of poor sleep in PCOS is high at 31%. The aim of this study was to explore the effect of auricular point acupressure (APA) pressure on sleep quality in women with PCOS. We verified the effect of APA pressure on sleep quality, quality of life, anxiety level, sex hormone indexes, and biochemical indexes in two groups after the intervention. So as to provide a sleep management strategy in PCOS women for future clinical practice guidelines.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Auricular point acupressure (APA)
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular point acupressure (APA)Other
Auricular point acupressure (APA) is a method derived from Traditional Chinese Medicine. PCOS women in the APA group began to apply pressure on the first day of enrollment. Patients were instructed to press each acupuncture point 3 times a day for 30 times. The PCOS woman is then trained to go to the outpatient clinic every 5-7 days to change the auricular acupressure sticker. The intervention period was 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| APA group | Experimental | Not described Receives: Other: Auricular point acupressure (APA) |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a cornerstone tool for the assessment of sleep quality
Measured: Baseline and 30 days
Secondary outcomes (6)
Modified Polycystic Ovary Syndrome Health Related Quality of Life Questionnaire (MPCOSQ)
Measured: Baseline and 30 days
Self-Rating Anxiety Scale (SAS)
The cutoff value for anxiety assessment of Self-Rating Anxiety Scale (SAS) is 50 oints, and the higher the score, the more obvious the anxiety tendency. Below 49 is normal; 50-59 is mild; 60-69 is moderate; A score of 69 or above is considered severe.
Measured: Baseline and 30 days
Testosterone (T) level(ng/mL）
Measured: Baseline and 30 days
Progesterone (P) level(ng/mL）
Measured: Baseline and 30 days
fasting serum insulin (pmol/L)
Measured: Baseline and 30 days
fasting blood-glucose(mmol/L)
Measured: Baseline and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start24 Jul 2022
- Primary completion1 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009172
- Sponsor's protocol ID
- XMYY-2022KY055-01
- Status last verified
- Aug 2023
- First submitted
- 19 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Auricular Point Acupressure on Sleep Quality in Women With Polycystic Ovary Syndrome：A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06009172
- Acronym / sponsor ID
- XMYY-2022KY055-01
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 24 Jul 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 24 Aug 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.
Women with polycystic ovary syndrome (PCOS) appear to have an increased frequency of sleep problems. The aim of this study was to explore the effect of auricular point acupressure (APA) pressure on sleep quality in women with PCOS.
Detailed description
Polycystic ovary syndrome (PCOS) is a prevalent disorder affecting 5-18% of reproductive-age women. In recent years, women with PCOS appear to have an increased frequency of sleep problems, and the prevalence of poor sleep in PCOS is high at 31%. The aim of this study was to explore the effect of auricular point acupressure (APA) pressure on sleep quality in women with PCOS. We verified the effect of APA pressure on sleep quality, quality of life, anxiety level, sex hormone indexes, and biochemical indexes in two groups after the intervention. So as to provide a sleep management strategy in PCOS women for future clinical practice guidelines.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APA group | Experimental | Other: Auricular point acupressure (APA) |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Auricular point acupressure (APA)Auricular point acupressure (APA) is a method derived from Traditional Chinese Medicine. PCOS women in the APA group began to apply pressure on the first day of enrollment. Patients were instructed to press each acupuncture point 3 times a day for 30 times. The PCOS woman is then trained to go to the outpatient clinic every 5-7 days to change the auricular acupressure sticker. The intervention period was 4 weeks. | Other | APA group |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and 30 days
The PSQI is a cornerstone tool for the assessment of sleep quality
6 secondary outcomes
Modified Polycystic Ovary Syndrome Health Related Quality of Life Questionnaire (MPCOSQ)
Time frame: Baseline and 30 days
Self-Rating Anxiety Scale (SAS)
Time frame: Baseline and 30 days
Testosterone (T) level(ng/mL）
Time frame: Baseline and 30 days
Progesterone (P) level(ng/mL）
Time frame: Baseline and 30 days
fasting serum insulin (pmol/L)
Time frame: Baseline and 30 days
fasting blood-glucose(mmol/L)
Time frame: Baseline and 30 days
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 28 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular point acupressure (APA) in people with Polycystic Ovary Syndrome, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 Aug 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 China. 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?
Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline and 30 days). 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 28 Aug 2023.