Sleep Disorder; Insomnia TypeNCT06730178
Using Generalized Estimating Equation Analysis in a Study of Relaxation Training in Patients With Insomnia.
A study testing relaxation training in people with Sleep Disorder; Insomnia Type, run by Calo Psychiatric Center.
Trial summary
Background: The purpose of this study was to examine the improvement in insomnia patients using Relaxation Training, and to use the Generalized Estimating Equation model (GEE-I) to analyze the results of repeated measurements and observe the difference between the subjective perception and the objective measurement of… Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder; Insomnia Type
- What is being tested?
- relaxation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 30 Oct 2009
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All subjects had been diagnosed as having primary insomnia or insomnia related to medical and psychiatric comorbid diagnoses using the D Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnostic criteria.
Who cannot join
- Patients who had comorbid serious medical illnesses, and pregnant and lactating women were excluded.
About this study
Official title: Calo Psychiatric Center
Background: The purpose of this study was to examine the improvement in insomnia patients using Relaxation Training, and to use the Generalized Estimating Equation model (GEE-I) to analyze the results of repeated measurements and observe the difference between the subjective perception and the objective measurement of sleep duration.
Methods: There were 24 subjects diagnosed as insomnia who completed the treatment course and 5 times evaluation. Of the 24 subjects, 7 accepted the sleep electroencephalogram (EEG). Relaxation training shortened the duration of sleep onset time and decreased the frequency of night awakening.
Read the detailed description
Of 47 qualified subjects, 24 volunteers took part in this study after the researchers had explained the study process.The patients were asked to keep a sleep diary. In the diaries, they recorded the time they went to bed and fell asleep, the duration to sleep onset (from "go to the bed" to "fall asleep"), the frequency of night waking, the time of getting up, and any medication history. Patients were instructed to perform the treatment in the evening, preferably just before bedtime, total time was 15 minutes.The patients recorded their sleep conditions every day and underwent relaxation training intervention for 4 weeks.
- Conditions
- Sleep Disorder; Insomnia Type
- Being tested
- relaxation training
- Keywords
- Insomnia, Relaxation Training, Generalized Estimating Equation
- Medical subject headings
- Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relaxation trainingBehavioural
The training tapes used were meditation relaxation training tapes translated form Jacobson progressive relaxation technique with copyrights. The tapes were recorded by a male therapist. Participants were instructed to perform the treatment in the evening, preferably just before bedtime, total time was 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation training in patients with insomnia | Experimental | The goals and processes of relaxation training were explained by therapists. The patients were asked to record data before relaxation training, inclusive of all sleep durations, the frequency of night waking, the time needed to fall asleep, and medication history. The insomnia scales were completed again one week later, and the relaxation training started in the second week. The patients recorded their sleep conditions every day and underwent relaxation training intervention for 4 weeks. Receives: Behavioral: relaxation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
the improvement of relaxation training tape
Participants were instructed to perform the treatment in the evening, preferably just before bedtime, total time was 15 minutes.
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 posted12 Dec 2024
- Study start1 Jan 2009
- Primary completion30 Oct 2009
- Study completion30 Oct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorder; Insomnia TypeStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All insomnia patients were asked to complete the insomnia scales. The goals and processes of relaxation training were explained by therapists. The patients were asked to record data before relaxation training, inclusive of all sleep durations, the frequency of night waking, the time needed to fall asleep, and medication history. The insomnia scales were completed again one week later, and the relaxation training started in the second week. The patients recorded their sleep conditions every day and underwent relaxation training intervention for 4 weeks. They were treated similarly, four times in total.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calo Psychiatric Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- For-Wey Lung, MD, ScD, Principal investigator, Calo Psychiatric Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730178
- Sponsor's protocol ID
- 9802
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data in this study are available to other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calo Psychiatric Center
- ClinicalTrials.gov ID
- NCT06730178
- Acronym / sponsor ID
- 9802
- Conditions
- Sleep Disorder; Insomnia Type
- Keywords
- Insomnia, Relaxation Training, Generalized Estimating Equation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Calo Psychiatric CenterUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 30 Oct 2009 (actual)
- Study completion
- 30 Oct 2009 (actual)
- First posted
- 12 Dec 2024 (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.
Background: The purpose of this study was to examine the improvement in insomnia patients using Relaxation Training, and to use the Generalized Estimating Equation model (GEE-I) to analyze the results of repeated measurements and observe the difference between the subjective perception and the objective measurement of sleep duration.
Methods: There were 24 subjects diagnosed as insomnia who completed the treatment course and 5 times evaluation. Of the 24 subjects, 7 accepted the sleep electroencephalogram (EEG). Relaxation training shortened the duration of sleep onset time and decreased the frequency of night awakening.
Detailed description
Of 47 qualified subjects, 24 volunteers took part in this study after the researchers had explained the study process.The patients were asked to keep a sleep diary. In the diaries, they recorded the time they went to bed and fell asleep, the duration to sleep onset (from "go to the bed" to "fall asleep"), the frequency of night waking, the time of getting up, and any medication history. Patients were instructed to perform the treatment in the evening, preferably just before bedtime, total time was 15 minutes.The patients recorded their sleep conditions every day and underwent relaxation training intervention for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All insomnia patients were asked to complete the insomnia scales. The goals and processes of relaxation training were explained by therapists. The patients were asked to record data before relaxation training, inclusive of all sleep durations, the frequency of night waking, the time needed to fall asleep, and medication history. The insomnia scales were completed again one week later, and the relaxation training started in the second week. The patients recorded their sleep conditions every day and underwent relaxation training intervention for 4 weeks. They were treated similarly, four times in total.
| Arm | Type | Receives |
|---|---|---|
| Relaxation training in patients with insomnia | Experimental | Behavioral: relaxation trainingThe goals and processes of relaxation training were explained by therapists. The patients were asked to record data before relaxation training, inclusive of all sleep durations, the frequency of night waking, the time needed to fall asleep, and medication history. The insomnia scales were completed again one week later, and the relaxation training started in the second week. The patients recorded their sleep conditions every day and underwent relaxation training intervention for 4 weeks. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All subjects had been diagnosed as having primary insomnia or insomnia related to medical and psychiatric comorbid diagnoses using the D Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnostic criteria.
Key exclusion criteria (1 listed)
- Patients who had comorbid serious medical illnesses, and pregnant and lactating women were excluded.
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 |
|---|---|---|
| relaxation trainingThe training tapes used were meditation relaxation training tapes translated form Jacobson progressive relaxation technique with copyrights. The tapes were recorded by a male therapist. Participants were instructed to perform the treatment in the evening, preferably just before bedtime, total time was 15 minutes. | Behavioural | Relaxation training in patients with insomnia |
Primary outcome
the improvement of relaxation training tape
Time frame: 4 weeks
Participants were instructed to perform the treatment in the evening, preferably just before bedtime, total time was 15 minutes.
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 12 Dec 2024.
- Individual participant dataSharing planned: No. The data in this study are available to other researchers 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.
For-Wey Lung, MD, ScD principal investigator
Calo Psychiatric Center
Questions about this trial
What is this clinical trial studying?
A study testing relaxation training in people with Sleep Disorder; Insomnia Type, run by Calo Psychiatric Center.
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 1 inclusion and 1 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 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
the improvement of relaxation training tape (time frame: 4 weeks). 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 12 Dec 2024.