Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536218
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Sleep Disorder Mindfulness Stress Reduction Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Mindfulness Stress Reduction Program on Sleep Status Stress and Quality of Life in Patients With Sleep Disorders A Polysomnographic Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sleep problems ranging from mild sleep disturbance to debilitating insomnia are among the most common health problems occurring in adults with an estimated prevalence of 35 to 48 Morin et al 2009 Mai and Buyss 2008 Insomnia is a fairly common sleep disorder characterized by difficulty falling asleep difficulty staying asleep or waking up too early despite adequate sleep opportunity recurring at least three times a week and accompanied by significant stress or distress during the day Morin and Jarrin 2013 According to the American guidelines for the treatment of chronic insomnia published in 2017 pharmacotherapy and non-pharmacological treatment are the two main treatment methods for sleep disorders Sateia et al 2017 Mindfulness-based stress reduction MBSR is an important type of non-pharmacological mindfulness-based intervention that effectively relieves insomnia by decentering Banno et al 2019Regarding the effect of mindfulness intervention in sleep disorders Ong and Moore suggest that mindfulness can improve sleep by reducing both primary and secondary arousal Ong and Moore 2020Therefore this study aims to expand the existing investigations by examining whether mindfulness meditation MBSR is associated with changes in objectively measured polysomnographic PSG sleep profiles of patients with sleep disorders who applied to the Sleep EMG department of Muş State Hospital and to examine the changes in PSG sleep in the context of a randomized controlled trial It aims to determine the effect on quality of life by associating it with subjectively reported sleep and stress changes
Detailed Description:
Sleep problems ranging from mild sleep disturbance to debilitating insomnia are among the most common health problems occurring in adults with an estimated prevalence of 35 to 48 Morin et al 2009 Mai and Buyss 2008 Insomnia is a fairly common sleep disorder characterized by difficulty falling asleep difficulty staying asleep or waking up too early despite adequate sleep opportunity recurring at least three times a week and accompanied by significant stress or distress during the day Morin and Jarrin 2013 According to the American guidelines for the treatment of chronic insomnia published in 2017 pharmacotherapy and non-pharmacological treatment are the two main treatment methods for sleep disorders Sateia et al 2017 Mindfulness-based stress reduction MBSR is an important type of non-pharmacological mindfulness-based intervention that effectively relieves insomnia by decentering Banno et al 2019Regarding the effect of mindfulness intervention in sleep disorders Ong and Moore suggest that mindfulness can improve sleep by reducing both primary and secondary arousal Ong and Moore 2020A limited but growing body of evidence suggests that mindfulness and other types of meditation may improve sleep quality Neuondorf et al 2015 reviewed 112 research studies of insomnia or sleep disturbance testing a variety of different mind-body interventions including meditation and found that although the evidence was heterogeneous limited and potentially biased mind-body training was a treatment option for patients It has been shown that it can be accepted as Neuendorf et al 2015 A recent systematic review and meta-analysis focused on identifying and evaluating the clinical significance of different mindfulness-based interventions MBI on sleep in individuals with anxiety and depression showing significant effects on sleep problem improvement across all MBI programs Chan et al al 2022 Therefore this study aims to expand the existing investigations by examining whether mindfulness meditation MBSR is associated with changes in objectively measured polysomnographic PSG sleep profiles of patients with sleep disorders who applied to the Sleep EMG department of Muş State Hospital and to examine the changes in PSG sleep in the context of a randomized controlled trial It aims to determine the effect on quality of life by associating it with subjectively reported sleep and stress changes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None