Insomnia ChronicNCT03623438
Self-administered Acupressure for Insomnia Disorder
A study testing Self-administered acupressure group and Sleep hygiene education (SHE) group in people with Insomnia Chronic, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The study is to evaluate the clinical effects of self-administered acupressure for treating insomnia disorder delivered by a training course. Subjects will be offered either self-administered acupressure training or sleep hygiene education. Their insomnia severity will be compared after 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Insomnia Chronic
- What is being tested?
- Self-administered acupressure group and Sleep hygiene education (SHE) group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2018to 12 Jan 2021
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chinese Hong Kong residents who are able to communicate in Cantonese or Putonghua;
- Aged 18-64 years;
- A current clinical DSM-5 diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire (BIQ)
- Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level; and
- Willing to give informed consent and comply with the trial protocol.
Who cannot join
- Receiving acupuncture or practitioner-delivered acupressure treatment in the past 6 months;
- Pregnancy;
- Cognitive impairment as indicated by a Mini Mental State Examination ≤23;
- At significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥3) ;
- No comorbid sleep disorders primarily requiring other treatment, such as sleep apnea or narcolepsy;
- Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline; and
- Shift-workers/
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Nursing, the Hong Kong Polytechnic University
Hong Kong
About this study
Official title: Self-administered Acupressure for Insomnia Disorder: A Randomized Controlled Trial
The study is to evaluate the clinical effects of self-administered acupressure for treating insomnia disorder delivered by a training course. Subjects will be offered either self-administered acupressure training or sleep hygiene education. Their insomnia severity will be compared after 8 weeks.
Read the detailed description
Objectives: To evaluate the clinical effects of self-administered acupressure for treating insomnia disorder delivered by a training course.
Hypothesis: Subjects in the self-administered acupressure group will have greater improvement in insomnia symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at 4 weeks and 8 weeks.
Design and subjects: A randomized controlled trial. 184 subjects with insomnia disorder recruited from the community will be randomized to self-administered acupressure or SHE 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-administered acupressure group will attend two training lessons (2-hour each) to learn self-administered acupressure and practice it every night for 4 weeks; subjects in the SHE group will receive sleep hygiene education with the schedule and duration that are same to the self-administered acupressure group.
Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters by subjective sleep diary and objective actigraphy, Hospital Anxiety and Depression Scale, and SF-6D at 4 and 8 weeks. Acceptability and compliance of self-administered acupressure will be evaluated.
Data Analysis: Differences in the questionnaire scores, subjective and objective sleep parameters will be examined using a mixed-effects model.
- Conditions
- Insomnia Chronic
- Being tested
- Self-administered acupressure group, Sleep hygiene education (SHE) group
- 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-administered acupressure groupBehavioural
Subjects in the self-administered acupressure group will attend an acupressure training course (2 sessions, 2 hours each) to learn self-administered acupressure, which will then be performed every night for 4 weeks.
Sleep hygiene education (SHE) groupBehavioural
Subjects in the comparison group will receive sleep hygiene education (2 sessions, 2 hours each, same as the treatment group) and be reminded to follow the sleep hygiene practice daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Self-administered acupressure group | Experimental | Subjects will attend two weekly 120-minute of self-administered acupressure training Receives: Behavioral: Self-administered acupressure group |
| Sleep hygiene education (SHE) group | Active comparator | Subjects will attend two weekly 120-minute of sleep hygiene education Receives: Behavioral: Sleep hygiene education (SHE) group |
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, distress and functional impairment associated with insomnia on a 5-point Likert scale. The total score will be reported. The score ranges from 0 to 28; a higher score indicates a more severe condition.
Measured: Week 8
Secondary outcomes (4)
The 7-day daily sleep diary
The standardized sleep diary records the daily sleep parameters.
Measured: Baseline, Week 4, Week8
Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item self-administrated questionnaire, which assesses the severity of depressive and anxiety symptoms. The anxiety and depression subscore will be reported. The subscore ranges from 0 to 21; a higher score indicates a more severe condition.
Measured: Baseline, Week 4, Week8
The 7-day actigraphy
An actigraph is a watch-like device used to estimate sleep-wake schedules by measuring activity.
Measured: Baseline, Week 4, Week8
Short Form- 6 Dimensions
It is a preference-based measure of health derived from the Short Form-36. It includes six dimensions: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality. The total score will be reported. The score ranges from 0 to 1; a higher score indicates a better outcome.
Measured: Baseline, Week 4, Week8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Sep 2018
- Primary completion30 Aug 2020
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623438
- Sponsor's protocol ID
- SelfAcupInsomnia
- Status last verified
- Oct 2019
- First submitted
- 6 Aug 2018
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon request
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-administered Acupressure for Insomnia Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03623438
- Acronym / sponsor ID
- SelfAcupInsomnia
- Conditions
- Insomnia Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 9 Aug 2018 (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 study is to evaluate the clinical effects of self-administered acupressure for treating insomnia disorder delivered by a training course. Subjects will be offered either self-administered acupressure training or sleep hygiene education. Their insomnia severity will be compared after 8 weeks.
Detailed description
Objectives: To evaluate the clinical effects of self-administered acupressure for treating insomnia disorder delivered by a training course.
Hypothesis: Subjects in the self-administered acupressure group will have greater improvement in insomnia symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at 4 weeks and 8 weeks.
Design and subjects: A randomized controlled trial. 184 subjects with insomnia disorder recruited from the community will be randomized to self-administered acupressure or SHE 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-administered acupressure group will attend two training lessons (2-hour each) to learn self-administered acupressure and practice it every night for 4 weeks; subjects in the SHE group will receive sleep hygiene education with the schedule and duration that are same to the self-administered acupressure group.
Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters by subjective sleep diary and objective actigraphy, Hospital Anxiety and Depression Scale, and SF-6D at 4 and 8 weeks. Acceptability and compliance of self-administered acupressure will be evaluated.
Data Analysis: Differences in the questionnaire scores, subjective and objective 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-administered acupressure group | Experimental | Behavioral: Self-administered acupressure groupSubjects will attend two weekly 120-minute of self-administered acupressure training |
| Sleep hygiene education (SHE) group | Active comparator | Behavioral: Sleep hygiene education (SHE) groupSubjects will attend two weekly 120-minute of sleep hygiene education |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chinese Hong Kong residents who are able to communicate in Cantonese or Putonghua;
- Aged 18-64 years;
- A current clinical DSM-5 diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire (BIQ)
- Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level; and
- Willing to give informed consent and comply with the trial protocol.
Key exclusion criteria (7 listed)
- Receiving acupuncture or practitioner-delivered acupressure treatment in the past 6 months;
- Pregnancy;
- Cognitive impairment as indicated by a Mini Mental State Examination ≤23;
- At significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥3) ;
- No comorbid sleep disorders primarily requiring other treatment, such as sleep apnea or narcolepsy;
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-administered acupressure groupSubjects in the self-administered acupressure group will attend an acupressure training course (2 sessions, 2 hours each) to learn self-administered acupressure, which will then be performed every night for 4 weeks. | Behavioural | Self-administered acupressure group |
| Sleep hygiene education (SHE) groupSubjects in the comparison group will receive sleep hygiene education (2 sessions, 2 hours each, same as the treatment group) and be reminded to follow the sleep hygiene practice daily for 4 weeks. | Behavioural | Sleep hygiene education (SHE) group |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Week 8
The ISI is a seven-item self-rating scale. The subjects rate the severity of insomnia, distress and functional impairment associated with insomnia on a 5-point Likert scale. The total score will be reported. The score ranges from 0 to 28; a higher score indicates a more severe condition.
4 secondary outcomes
The 7-day daily sleep diary
Time frame: Baseline, Week 4, Week8
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, Week 4, Week8
The 7-day actigraphy
Time frame: Baseline, Week 4, Week8
Short Form- 6 Dimensions
Time frame: Baseline, Week 4, Week8
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 14 Jan 2021.
- Individual participant dataSharing planned: Undecided. Upon request
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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 Self-administered acupressure group and Sleep hygiene education (SHE) group in people with Insomnia Chronic, 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 7 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 14 Jan 2021. 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?
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?
Insomnia Severity Index (ISI) (time frame: Week 8). 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 14 Jan 2021.