InsomniaNCT03053648
Self-acupressure for Insomnia
A study testing Self-acupressure and Sleep hygiene education in people with Insomnia and Acupressure, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Abstract Objectives: To explore the clinical effects of self-acupressure for treating insomnia delivered by a training course. Hypothesis: Subjects who have participated in the self-acupressure training course will have greater improvement in insomnia symptoms and daytime impairment than the sleep hygiene education… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Insomnia, Acupressure
- What is being tested?
- Self-acupressure and Sleep hygiene education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2016to 31 Mar 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- (1) Chinese Hong Kong residents who are able to communicate in Cantonese or Putonghua;
- (2) Aged 18 - 65 years;
- (3) A current clinical Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire (BIQ), a validated diagnostic tool. (The criteria include having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months.)
- (4) Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level; and
- (5) Willing to give informed consent and comply with the trial protocol.
Who cannot join
- (1) Receiving acupuncture or practitioner-delivered acupressure treatment in the past 6 months;
- (2) Pregnancy;
- (3) Cognitive impairment as indicated by a Mini Mental State Examination ≤ 23;
- (4) At significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥ 3);
- (5) No comorbid sleep disorders primarily requiring other treatment, such as sleep apnea or narcolepsy; and
- (6) Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline.
Trial locations and contacts
1 site in 1 country.
Wing-Fai Yeung contact
Hong Kong1 site, 1 recruiting
- Recruiting
School of Nursing, the Hong Kong Polytechnic University
Hong Kong
Wing-Fai Yeung, jerry-wf.yeung@polyu.edu.hk
About this study
Official title: Self-acupressure for Insomnia: A Pilot Randomized Controlled Trial
Abstract
Objectives: To explore the clinical effects of self-acupressure for treating insomnia delivered by a training course.
Read more
Hypothesis: Subjects who have participated in the self-acupressure training course will have greater improvement in insomnia symptoms and daytime impairment than the sleep hygiene education control group at 4 and 8 weeks.
Design and subjects: A pilot randomized controlled trial. Subjects with insomnia will be recruited from the community. 30 subjects will be randomized to self-acupressure and sleep hygiene education control groups in a 1: 1 ratio. Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and daytime impairment.
Interventions: Subjects in the self-acupressure group will attend two training sessions to learn self-acupressure and will practice self-acupressure every night for 4 weeks; subjects in the sleep hygiene education control group will receive two training sessions to learn sleep hygiene practice.
Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters using subjective sleep diary, Hospital Anxiety and Depression Scale, and SF-6D at 4 and 8 weeks. Acceptability and sustainability of self-acupressure will also be evaluated.
Data Analysis: Differences in the questionnaire scores, subjective sleep parameters will be examined using a mixed-effects model.
- Conditions
- Insomnia, Acupressure
- Being tested
- Self-acupressure, Sleep hygiene education
- Keywords
- Insomnia, Randomized controlled trial, Acupressure, Self-help
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-acupressureOther
The subjects will be told to perform self-acupressure 30 min before sleep for 20 min every night for 4 weeks. Telephone follow-up will be made twice a week by the trained student research assistant during the 4-week treatment period to remind subjects to practice self-acupressure.
Sleep hygiene educationOther
A training hand-out will be provided to each subject. The hand-outs included manualized sleep hygiene instructions. A registered nurse who has been trained by a clinical psychologist will be the instructor on sleep hygiene and activity scheduling. To enhance interaction and ensure the quality of teaching, each course will be conducted in a group of 5 participants.
| Study group | Role | What they receive |
|---|---|---|
| Self-acupressure Group | Experimental | Subjects in this group will attend two weekly 120-minute self-acupressure training sessions in a classroom at the School of Nursing, the Hong Kong Polytechnic University. The subjects will be instructed on how to perform the self-acupressure treatment by a trained instructor. To enhance interaction and ensure the quality of teaching, each course will be conducted in a small group of 6 participants. Subjects will perform self-acupressure daily for 4 consecutive weeks. Receives: Other: Self-acupressure |
| Sleep Hygiene Education Group | Active comparator | To control the contact time with professional person in the treatment group, participants in this group will receive two sessions of 120-minute sleep hygiene training session. The participants will be asked to follow the health hygiene instructions daily for 4 consecutive weeks. Receives: Other: Sleep hygiene education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
The ISI is a seven-item self-rating scale. The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point Likert scale.
Measured: 7 days
Secondary outcomes (3)
The 7-day daily sleep diary
The standardized sleep diary records the bedtime and rising time, from which the total time in bed (TIB) can be calculated. Subjects will be asked to estimate sleep-onset latency, wake after sleep onset, and total sleep time (TST). Sleep efficiency will be calculated as (TST/TIB * 100%).
Measured: 7 days
Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item self-administrated questionnaire, which assess the severity of depressive and anxiety symptoms.
Measured: 7 days
Short Form-6D (SF-6D)
SF-6D is composed of six multi-level dimensions: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start1 Dec 2016
- Primary completion3 Mar 2017 (estimated)
- Study completion31 Mar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wing-Fai Yeung, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053648
- Sponsor's protocol ID
- HSEAR 20161123005
- Status last verified
- Feb 2017
- First submitted
- 13 Feb 2017
- Last updated
- 16 Feb 2017
- 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 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-acupressure for Insomnia: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03053648
- Acronym / sponsor ID
- HSEAR 20161123005
- Conditions
- Insomnia, Acupressure
- Keywords
- Insomnia, Randomized controlled trial, Acupressure, Self-help
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 3 Mar 2017 (estimated)
- Study completion
- 31 Mar 2017 (estimated)
- First posted
- 15 Feb 2017 (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.
Abstract
Objectives: To explore the clinical effects of self-acupressure for treating insomnia delivered by a training course.
Hypothesis: Subjects who have participated in the self-acupressure training course will have greater improvement in insomnia symptoms and daytime impairment than the sleep hygiene education control group at 4 and 8 weeks.
Design and subjects: A pilot randomized controlled trial. Subjects with insomnia will be recruited from the community. 30 subjects will be randomized to self-acupressure and sleep hygiene education control groups in a 1: 1 ratio. Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and daytime impairment.
Interventions: Subjects in the self-acupressure group will attend two training sessions to learn self-acupressure and will practice self-acupressure every night for 4 weeks; subjects in the sleep hygiene education control group will receive two training sessions to learn sleep hygiene practice.
Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters using subjective sleep diary, Hospital Anxiety and Depression Scale, and SF-6D at 4 and 8 weeks. Acceptability and sustainability of self-acupressure will also be evaluated.
Data Analysis: Differences in the questionnaire scores, subjective sleep parameters will be examined using a mixed-effects model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-acupressure Group | Experimental | Other: Self-acupressureSubjects in this group will attend two weekly 120-minute self-acupressure training sessions in a classroom at the School of Nursing, the Hong Kong Polytechnic University. The subjects will be instructed on how to perform the self-acupressure treatment by a trained instructor. To enhance interaction and ensure the quality of teaching, each course will be conducted in a small group of 6 participants. Subjects will perform self-acupressure daily for 4 consecutive weeks. |
| Sleep Hygiene Education Group | Active comparator | Other: Sleep hygiene educationTo control the contact time with professional person in the treatment group, participants in this group will receive two sessions of 120-minute sleep hygiene training session. The participants will be asked to follow the health hygiene instructions daily for 4 consecutive weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- (1) Chinese Hong Kong residents who are able to communicate in Cantonese or Putonghua;
- (2) Aged 18 - 65 years;
- (3) A current clinical Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire (BIQ), a validated diagnostic tool. (The criteria include having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months.)
- (4) Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level; and
- (5) Willing to give informed consent and comply with the trial protocol.
Key exclusion criteria (6 listed)
- (1) Receiving acupuncture or practitioner-delivered acupressure treatment in the past 6 months;
- (2) Pregnancy;
- (3) Cognitive impairment as indicated by a Mini Mental State Examination ≤ 23;
- (4) At significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥ 3);
- (5) No comorbid sleep disorders primarily requiring other treatment, such as sleep apnea or narcolepsy; and
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 |
|---|---|---|
| Self-acupressureThe subjects will be told to perform self-acupressure 30 min before sleep for 20 min every night for 4 weeks. Telephone follow-up will be made twice a week by the trained student research assistant during the 4-week treatment period to remind subjects to practice self-acupressure. | Other | Self-acupressure Group |
| Sleep hygiene educationA training hand-out will be provided to each subject. The hand-outs included manualized sleep hygiene instructions. A registered nurse who has been trained by a clinical psychologist will be the instructor on sleep hygiene and activity scheduling. To enhance interaction and ensure the quality of teaching, each course will be conducted in a group of 5 participants. | Other | Sleep Hygiene Education Group |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: 7 days
The ISI is a seven-item self-rating scale. The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point Likert scale.
3 secondary outcomes
The 7-day daily sleep diary
Time frame: 7 days
Hospital Anxiety and Depression Scale (HADS)
Time frame: 7 days
Short Form-6D (SF-6D)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
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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.
Wing-Fai Yeung contact
Wing-Fai Yeung principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-acupressure and Sleep hygiene education in people with Insomnia and Acupressure, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 5 inclusion and 6 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 16 Feb 2017. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wing-Fai Yeung (jerry-wf.yeung@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: 7 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 16 Feb 2017.