Polysomnography Evaluation of a Practice of Mindfulness in Menopausal Patients With Insomnia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Sao Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Associação Fundo de Incentivo à Pesquisa
Information provided by (Responsible Party):
marcelo csermak garcia, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01593436
First received: April 23, 2012
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Primary Insomnia
Behavioral: mindfulness training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Polysomnography and Sleep Quality Evaluation Before and After a Practice of Mindfulness in Menopausal Patients With Insomnia

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • The investigators intend to evaluate the effectiveness of mindfulness training in postmenopausal women with insomnia [ Time Frame: two years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 54
Study Start Date: July 2011
Estimated Study Completion Date: July 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: mindfulness training
mindfulness training for patients with insomnia
Behavioral: mindfulness training
mindfulness interventions for 8 weeks for a group of menopausal insomniacs
Other Names:
  • mindfulness,
  • meditation,
  • sleep pattern in meditators women in menopause
No Intervention: polysomnography and actigraphy
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 66 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:Inclusion criteria for postmenopausal women with insomnia:

  • be available to attend any training program of mindfulness (1 time per week for 8 weeks) and perform the suggested practices home.
  • be available to perform the tests at home polysomnography (overnight) and other tests.
  • Be available to perform the blood collection
  • meet the criteria established in accordance with DSM-IV-TR for insomnia
  • age 50 to 65 years.
  • Women in menopause: women presenting with absence of menstruation in the past year and either FSH greater than 30.
  • Have a BMI value lower than 30.
  • Not having undergone any previous treatment against insomnia.
  • Not having made use of hypnotics for at least 15 days.

Inclusion criteria for women without menopausal insomnia

  • 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.
  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01593436

Locations
Brazil
Associacao Fundo de Incentivo a Psicofarmacologia Sao Paulo, SP, Brazil
Sao Paulo, SP, Brazil, 04017-001
Sponsors and Collaborators
University of Sao Paulo
Associação Fundo de Incentivo à Pesquisa
Investigators
Study Director: Luiz Eugênio A. Mello, advisor UNIFESP-Federal University of Sao Paulo
  More Information

No publications provided

Responsible Party: marcelo csermak garcia, principal investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01593436     History of Changes
Other Study ID Numbers: 0708/11
Study First Received: April 23, 2012
Last Updated: May 10, 2012
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: Associação Fundo de Incentivo à Pesquisa

Keywords provided by University of Sao Paulo:
insomnia,menopause, polysomnography, mindfulness

ClinicalTrials.gov processed this record on October 29, 2014