Insomnia, PrimaryNCT03155750
Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia
A study testing Zero Time Exercise and Sleep hygiene education in people with Insomnia, Primary, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Objectives: To evaluate the clinical effects of Zero-Time Exercise (ZTEx) for treating insomnia disorder delivered by a training course. Hypothesis: Subjects in the ZTEx training group will have greater improvement in insomnia symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia, Primary
- What is being tested?
- Zero Time Exercise and Sleep hygiene education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Jun 2017to 7 Sep 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18-65 years old;
- Chinese Hong Kong residents who are able to communicate in Cantonese or Mandarin;
- A current clinical Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) diagnosis of insomnia disorder (Primary in nature) 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;
- Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level;
- Willing to give informed consent and comply with the trial protocol;
- Ambulant and independent in activities of daily living;
- Physically inactive which refers to less than 150 minutes moderate-intensity activity per week or less than 75 minutes vigorous-intensity activity per week, or an equivalent combination of moderate- and vigorous- intensity activity.
Who cannot join
- Evidence of association of insomnia with medical conditions, other sleep disorders, or side-effects of medications;
- Use of medication or psychotherapeutic components for insomnia or other psychiatric disorders;
- Other possible psychiatric disorders including generalized anxiety disorder (GAD), major depressive disorder (MDD), posttraumatic stress disorder (PTSD), psychosis as screened by structural clinical interview of DSM-IV;
- cognitive impairment preventing informed consent or understanding of instructions (score < 22 in Montreal Cognitive Assessment Hong Kong version);
- Shift work;
- body mass index equal to or over 27.5, the obese criteria for Asians;
- Unsafe conditions or incapable to exercise as recommended by their physician.
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: Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia: A Pilot Randomized Controlled Trial
Objectives: To evaluate the clinical effects of Zero-Time Exercise (ZTEx) for treating insomnia disorder delivered by a training course.
Hypothesis: Subjects in the ZTEx training group will have greater improvement in insomnia symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at week 8.
Read more
Design and subjects: A randomized controlled trial. 32 inactive subjects with insomnia disorder recruited from the community will be randomized to ZTEx training 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 ZTEx training group will attend two training lessons (2-hour each) to learn ZTEx and practice it every night for 8 weeks; subjects in the SHE group will receive sleep hygiene education with the schedule and duration that are same to the ZTEx training 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, Multidimensional Fatigue Inventory-20 and Short Form-6 Dimension. Acceptability and compliance of ZTEx 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, Primary
- Being tested
- Zero Time Exercise, Sleep hygiene education
- Keywords
- insomnia
- 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.
Zero Time ExerciseOther
Zero Time Exercise encourage people to increase physical exercise by simple movements that can be done any time at any places. We offer a 2-session training course to train the subjects to do zero-time exercise.
Sleep hygiene educationOther
We offer a 2-session education course to teach the subjects about sleep hygiene practice.
| Study group | Role | What they receive |
|---|---|---|
| Zero Time Exercise training | Experimental | Subjects in this group will attend two 2-hour ZTEx training lessons. Each subject will receive a handout and an exercise log. The handout includes a picture-illustrating ZTEx step-by-step protocol. The exercise log is for them to record their time spending on performing the ZTEx every day during the 8-week study period. Receives: Other: Zero Time Exercise |
| sleep hygiene education | Active comparator | Subjects in this group will receive two 2-hour lessons of sleep hygiene education delivered by a registered nurse. 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
The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point
Measured: week 8
Secondary outcomes (9)
Sleep diary (7-day)
The standardized sleep diary records the daily bedtime and rising time, from which the total time in bed (TIB) can be calculated.
Measured: Baseline, week 4, week 8
Multidimensional fatigue inventory-20
Multidimensional fatigue inventory-20 is a 20-items self-report instrument designed to measure severity of fatigue.
Measured: Baseline, week 4, week 8
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale is a 14-items self-administered questionnaire, which assesses the severity of depressive and anxiety symptoms
Measured: Baseline, week 4, week 8
Actigraphy (7-day)
Actigraphy measures wrist movements to assess sleep or waking state, is accomplished through an accelerometer in a wrist worn device
Measured: Baseline, week 8
Short Form-6 Dimension
The Short Form-6 Dimension is composed of six multi-level dimensions to assess the quality of life which can be used in cost-utility analysis.
Measured: Baseline, week 4, week 8
Hand grip strength
Objective hand grip strength
Measured: Baseline, week 8
Level of activity
Self-report level of activity in moderate and vigorous intensity
Measured: Baseline, week4, week 8
Weight
Weight in kilograms; (Weight and Height will be combined to report as BMI in kg/m^2)
Measured: Baseline, week 8
Height
Height in meters; (Weight and Height will be combined to report as BMI in kg/m^2)
Measured: Baseline, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start5 Jun 2017
- Primary completion7 Sep 2017
- Study completion7 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insomnia, PrimaryStudies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YEUNG Wing Fai, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155750
- Sponsor's protocol ID
- ZTEInsomnia
- Status last verified
- Oct 2017
- First submitted
- 14 May 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yeung WF, Lai AY, Ho FY, Suen LK, Chung KF, Ho JY, Ho LM, Yu BY, Chan LY, Lam TH. Effects of Zero-time Exercise on inactive adults with insomnia disorder: a pilot randomized controlled trial. Sleep Med. 2018 Dec;52:118-127. doi: 10.1016/j.sleep.2018.07.025. Epub 2018 Aug 24.
PubMed 30312957
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03155750
- Acronym / sponsor ID
- ZTEInsomnia
- Conditions
- Insomnia, Primary
- Keywords
- insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 7 Sep 2017 (actual)
- Study completion
- 7 Sep 2017 (actual)
- First posted
- 16 May 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.
Objectives: To evaluate the clinical effects of Zero-Time Exercise (ZTEx) for treating insomnia disorder delivered by a training course.
Hypothesis: Subjects in the ZTEx training group will have greater improvement in insomnia symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at week 8.
Design and subjects: A randomized controlled trial. 32 inactive subjects with insomnia disorder recruited from the community will be randomized to ZTEx training 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 ZTEx training group will attend two training lessons (2-hour each) to learn ZTEx and practice it every night for 8 weeks; subjects in the SHE group will receive sleep hygiene education with the schedule and duration that are same to the ZTEx training 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, Multidimensional Fatigue Inventory-20 and Short Form-6 Dimension. Acceptability and compliance of ZTEx 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 |
|---|---|---|
| Zero Time Exercise training | Experimental | Other: Zero Time ExerciseSubjects in this group will attend two 2-hour ZTEx training lessons. Each subject will receive a handout and an exercise log. The handout includes a picture-illustrating ZTEx step-by-step protocol. The exercise log is for them to record their time spending on performing the ZTEx every day during the 8-week study period. |
| sleep hygiene education | Active comparator | Other: Sleep hygiene educationSubjects in this group will receive two 2-hour lessons of sleep hygiene education delivered by a registered nurse. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults age 18-65 years old;
- Chinese Hong Kong residents who are able to communicate in Cantonese or Mandarin;
- A current clinical Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) diagnosis of insomnia disorder (Primary in nature) 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;
- Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level;
- Willing to give informed consent and comply with the trial protocol;
Key exclusion criteria (7 listed)
- Evidence of association of insomnia with medical conditions, other sleep disorders, or side-effects of medications;
- Use of medication or psychotherapeutic components for insomnia or other psychiatric disorders;
- Other possible psychiatric disorders including generalized anxiety disorder (GAD), major depressive disorder (MDD), posttraumatic stress disorder (PTSD), psychosis as screened by structural clinical interview of DSM-IV;
- cognitive impairment preventing informed consent or understanding of instructions (score < 22 in Montreal Cognitive Assessment Hong Kong version);
- Shift work;
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 |
|---|---|---|
| Zero Time ExerciseZero Time Exercise encourage people to increase physical exercise by simple movements that can be done any time at any places. We offer a 2-session training course to train the subjects to do zero-time exercise. | Other | Zero Time Exercise training |
| Sleep hygiene educationWe offer a 2-session education course to teach the subjects about sleep hygiene practice. | Other | sleep hygiene education |
Primary outcome
Insomnia Severity Index
Time frame: week 8
The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point
9 secondary outcomes
Sleep diary (7-day)
Time frame: Baseline, week 4, week 8
Multidimensional fatigue inventory-20
Time frame: Baseline, week 4, week 8
Hospital Anxiety and Depression Scale
Time frame: Baseline, week 4, week 8
Actigraphy (7-day)
Time frame: Baseline, week 8
Short Form-6 Dimension
Time frame: Baseline, week 4, week 8
Hand grip strength
Time frame: Baseline, week 8
Level of activity
Time frame: Baseline, week4, week 8
Weight
Time frame: Baseline, week 8
Height
Time frame: Baseline, 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 20 Oct 2017.
- Derived from this study: PubMed 30312957Yeung WF, Lai AY, Ho FY, Suen LK, Chung KF, Ho JY, Ho LM, Yu BY, Chan LY, Lam TH. Effects of Zero-time Exercise on inactive adults with insomnia disorder: a pilot randomized controlled trial. Sleep Med. 2018 Dec;52:118-127. doi: 10.1016/j.sleep.2018.07.025. Epub 2018 Aug 24.
- 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.
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 Zero Time Exercise and Sleep hygiene education in people with Insomnia, Primary, 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 7 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 20 Oct 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?
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 (time frame: week 8). 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 NCT03155750, which also lists 1 linked publication.
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 20 Oct 2017.