Primary InsomniaNCT01593436
Mindfulness and RelaxationTraining for Insomnia (MRTI) on Postmenopausal Women: a Randomized Clinical Trial.
A study testing mindfulness training in people with Primary Insomnia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Summary Introduction: Insomnia is a symptom of sleep disorders most prevalent. Primary insomnia, the investigators analyzed, often related to stress states acquired, generalized anxiety and stress, which are important factors that disrupt normal sleep. Read more about this study
- Who is it for?
- Ages 50 to 66 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- mindfulness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2011to Jul 2015
- 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 50 to 66 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be available to perform the examinations polysomnographic (overnight) and other tests.
- To meditators, having trained as a practice of mindfulness meditation for at least 3 years 3 times a week.
- Age: 50 to 65 years
- Being a woman and being in menopause: women presenting failures or lack of regular menstrual periods last year.
- Exclusion Criteria:Exclusion criteria for menopausal women with insomnia
- being under drug treatment, subjects will not be accepted that use of benzodiazepines, antihistamines, hypnotics, herbal sleeping pills, sedatives, antidepressants, antipsychotics, stimulants (amphetamine, caffeine, modafinil), corticosteroids, bronchodilators and beta blockers.
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- being under psychological or psychiatric treatment.
- present history of neurological or psychiatric diseases such as severe psychotic disorders.
- having other sleep disorders like narcolepsy, sleep-disordered breathing, sleep apnea with an index greater than 15 / h, circadian rhythm disorder or parasomnias.
- 4 years of schooling below complete primary school
- Exclusion criteria for menopausal women without complaints of insomnia:
- being under drug treatment, subjects will not be accepted that use of benzodiazepines, antihistamines, hypnotics, herbal sleeping pills, sedatives, antidepressants, antipsychotics, stimulants (amphetamine, caffeine, modafinil), corticosteroids, bronchodilators and beta blockers.
- being in psychological treatments.
- having had contact with a meditation technique.
- present history of neurological or psychiatric diseases such as severe psychotic disorders, as well as anxiety and depression.
- women presenting failures or regular period last year.
- 4 years of schooling below complete primary school
- submit any sleep disorders
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Associacao Fundo de Incentivo a Psicofarmacologia Sao Paulo, SP, Brazil
São Paulo, São Paulo, 04017-001
About this study
Official title: The Effects of Mindfulness and RelaxationTraining for Insomnia (MRTI) on Postmenopausal Women: a Randomized Clinical Trial.
Summary
Introduction: Insomnia is a symptom of sleep disorders most prevalent. Primary insomnia, the investigators analyzed, often related to stress states acquired, generalized anxiety and stress, which are important factors that disrupt normal sleep. The investigators point out a fact that still intrigue the students of medicine and sleep that is distorted perception of sleep by the sleepless nights, polysomnography shows greater effectiveness than that perceived by them. On the other hand, there is evidence that mindfulness techniques may reduce symptoms of stress and anxiety as well as improve the general attention, which may contribute to a better perception of the effectiveness of sleep. In addition, there are studies showing that meditation is associated with metabolic and neurophysiological characteristics similar to normal sleep. Objectives: To compare sleepless menopausal women trained for 8 weeks in the technique of mindfulness insomniac postmenopausal untrained and also assess the quality of sleep experienced meditators menopausal comparing them to the group of healthy postmenopausal women untrained in the art.
Read the detailed description
Groups will be assessed by actigraphy, polysomnography and questionnaires for assessing stress, depression, anxiety, quality of life, self-pity, subjective states such as sedation and other physical or mental attitudes, vitality, emotional state and attentiveness. Moreover, prospective memory participants will be evaluated by means of a task as close as possible to real life conditions of the volunteers (green) and also the working memory is assessed by a test called specific counting span. Menopausal women will be evaluated for the presence or absence of bruxism compared to ordinary meditators, all postmenopausal.
- Conditions
- Primary Insomnia
- Being tested
- mindfulness training
- Keywords
- insomnia,menopause, polysomnography, mindfulness
- 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.
mindfulness trainingBehavioural
Also called mindfulness,, meditation,, sleep pattern in meditators women in menopause
mindfulness interventions for 8 weeks for a group of menopausal insomniacs
| Study group | Role | What they receive |
|---|---|---|
| mindfulness training | Active comparator | mindfulness training for patients with insomnia Receives: Behavioral: mindfulness training |
| polysomnography and actigraphy | No intervention | The intention is to assess the sleep architecture of meditators and non meditators women without menopausal insomnia by polysomnographic , actigraphy, and questionnaires to assess sleep quality and emotional state |
What is being measured
The primary outcome is the main question the study is designed to answer.
The investigators intend to evaluate the effectiveness of mindfulness training in postmenopausal women with insomnia
The insomniacs were trained for 8 weeks in mindfullness,and they had a 30-minute meditation class once a week. They also received a meditation audio,to practice three times a day for 15 minutes in their homes.The control group was not infirm intervention. The meditation group showed relief of the symptoms of insomnia, indicated by Pittsburgh Insomnia Index, actigraphy and polysomnography, improving the overall quality of sleep and decreasing number of awakening.The control group remained with the same symptoms and complaints of insomnia.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startJul 2011
- Primary completionNov 2011
- Study completionJul 2015
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 Primary InsomniaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Associação Fundo de Incentivo à Pesquisa
- Responsible party
- Principal investigator, marcelo csermak garcia, University of Sao Paulo
- Investigators
- Helena hachul Campos, advisor, Study director, UNIFESP-Federal University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593436
- Sponsor's protocol ID
- 0708/11
- Status last verified
- Apr 2018
- First submitted
- 23 Apr 2012
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Garcia MC, Kozasa EH, Tufik S, Mello LEAM, Hachul H. The effects of mindfulness and relaxation training for insomnia (MRTI) on postmenopausal women: a pilot study. Menopause. 2018 Sep;25(9):992-1003. doi: 10.1097/GME.0000000000001118.
PubMed 29787483
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mindfulness and RelaxationTraining for Insomnia (MRTI) on Postmenopausal Women: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01593436
- Acronym / sponsor ID
- 0708/11
- Conditions
- Primary Insomnia
- Keywords
- insomnia,menopause, polysomnography, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Associação Fundo de Incentivo à Pesquisa
- Study start
- Jul 2011 (actual)
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 8 May 2012 (estimated)
- 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.
Summary
Introduction: Insomnia is a symptom of sleep disorders most prevalent. Primary insomnia, the investigators analyzed, often related to stress states acquired, generalized anxiety and stress, which are important factors that disrupt normal sleep. The investigators point out a fact that still intrigue the students of medicine and sleep that is distorted perception of sleep by the sleepless nights, polysomnography shows greater effectiveness than that perceived by them. On the other hand, there is evidence that mindfulness techniques may reduce symptoms of stress and anxiety as well as improve the general attention, which may contribute to a better perception of the effectiveness of sleep. In addition, there are studies showing that meditation is associated with metabolic and neurophysiological characteristics similar to normal sleep. Objectives: To compare sleepless menopausal women trained for 8 weeks in the technique of mindfulness insomniac postmenopausal untrained and also assess the quality of sleep experienced meditators menopausal comparing them to the group of healthy postmenopausal women untrained in the art.
Detailed description
Groups will be assessed by actigraphy, polysomnography and questionnaires for assessing stress, depression, anxiety, quality of life, self-pity, subjective states such as sedation and other physical or mental attitudes, vitality, emotional state and attentiveness. Moreover, prospective memory participants will be evaluated by means of a task as close as possible to real life conditions of the volunteers (green) and also the working memory is assessed by a test called specific counting span. Menopausal women will be evaluated for the presence or absence of bruxism compared to ordinary meditators, all postmenopausal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mindfulness training | Active comparator | Behavioral: mindfulness trainingmindfulness training for patients with insomnia |
| polysomnography and actigraphy | No intervention | –The intention is to assess the sleep architecture of meditators and non meditators women without menopausal insomnia by polysomnographic , actigraphy, and questionnaires to assess sleep quality and emotional state |
Who may qualify
- Ages
- 50 to 66 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- be available to perform the examinations polysomnographic (overnight) and other tests.
- To meditators, having trained as a practice of mindfulness meditation for at least 3 years 3 times a week.
- Age: 50 to 65 years
- Being a woman and being in menopause: women presenting failures or lack of regular menstrual periods last year.
- Exclusion Criteria:Exclusion criteria for menopausal women with insomnia
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| mindfulness trainingAlso: mindfulness,, meditation,, sleep pattern in meditators women in menopausemindfulness interventions for 8 weeks for a group of menopausal insomniacs | Behavioural | mindfulness training |
Primary outcome
The investigators intend to evaluate the effectiveness of mindfulness training in postmenopausal women with insomnia
Time frame: two years
The insomniacs were trained for 8 weeks in mindfullness,and they had a 30-minute meditation class once a week. They also received a meditation audio,to practice three times a day for 15 minutes in their homes.The control group was not infirm intervention. The meditation group showed relief of the symptoms of insomnia, indicated by Pittsburgh Insomnia Index, actigraphy and polysomnography, improving the overall quality of sleep and decreasing number of awakening.The control group remained with the same symptoms and complaints of insomnia.
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 3 May 2018.
- Derived from this study: PubMed 29787483Garcia MC, Kozasa EH, Tufik S, Mello LEAM, Hachul H. The effects of mindfulness and relaxation training for insomnia (MRTI) on postmenopausal women: a pilot study. Menopause. 2018 Sep;25(9):992-1003. doi: 10.1097/GME.0000000000001118.
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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.
Helena hachul Campos, advisor study director
UNIFESP-Federal University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness training in people with Primary Insomnia, run by University of Sao Paulo at 1 site in Brazil.
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 18 inclusion and 0 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 3 May 2018. 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 Brazil. 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?
The investigators intend to evaluate the effectiveness of mindfulness training in postmenopausal women with insomnia (time frame: two years). 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 NCT01593436, 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 3 May 2018.