Polysomnography Evaluation of a Practice of Mindfulness in Menopausal Patients With Insomnia
Recruitment status was Active, not recruiting
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.
|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|
- 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.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||July 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Active Comparator: mindfulness training
mindfulness training for patients with insomnia
Behavioral: mindfulness training
mindfulness interventions for 8 weeks for a group of menopausal insomniacs
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593436
|Associacao Fundo de Incentivo a Psicofarmacologia Sao Paulo, SP, Brazil|
|Sao Paulo, SP, Brazil, 04017-001|
|Study Director:||Luiz Eugênio A. Mello, advisor||UNIFESP-Federal University of Sao Paulo|