Patients in the Sleep ClinicNCT06536218
Sleep Disorder Mindfulness Stress Reduction Intervention
A study testing CONSCIOUS AWARENESS STRESS REDUCTION PROGRAM APPLICATION in people with Patients in the Sleep Clinic, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients in the Sleep Clinic
- What is being tested?
- CONSCIOUS AWARENESS STRESS REDUCTION PROGRAM APPLICATION
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 Sep 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65
- Knowing how to read and write
- Being able to speak Turkish fluently
- Being diagnosed with a sleep disorder as a result of Polysomnography
Who cannot join
- • Being diagnosed with any mental illness
- Using any psychotropic medication
- Having a chronic disease that prevents you from doing exercises
- Participating in any awareness-based training program in the last year
- Being diagnosed with obstructive sleep apnea syndrome (OSAS)
- Being diagnosed with narcolepsy
Show all 12Show fewer
- Randomization Criteria In this study, individuals;
- Age,
- Gender,
- Sleep quality scale score,
- Perceived Stress Scale score
- Will be randomized according to quality of life scale scores.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mindfulness Stress Reduction Program on Sleep Status, Stress and Quality of Life in Patients With Sleep Disorders: A Polysomnographic Study
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., 2019).Regarding 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, 2020).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.
Read the 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., 2019).Regarding 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, 2020).A 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.
- Conditions
- Patients in the Sleep Clinic
- Being tested
- CONSCIOUS AWARENESS STRESS REDUCTION PROGRAM APPLICATION
- Keywords
- SLEEPING DISORDER, POLYSOMNOGRAPHIC RESEARCH, CONSCIOUS AWARENESS, LIFE QUALITY, STRESS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONSCIOUS AWARENESS STRESS REDUCTION PROGRAM APPLICATIONBehavioural
CONSCIOUS AWARENESS STRESS REDUCTION PROGRAM APPLICATION Conscious Awareness Based Stress Reduction (BFTSA) intervention consists of seven sessions in total and is planned to be completed in a total of seven weeks, with one session per week and each session being 45 minutes. After the results of the PSG patients are determined according to the randomization criteria, they receive certain points from the sleep scale, it is planned to call the patients by phone and explain the meaning and importance of the study, the applications to be performed in the study and its duration. It is planned to hold online individual interviews with patients who agree to participate in this study.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | It is planned to conduct a one-session (60-minute), unstructured, active participation-based group application (the week when the first session is applied to the intervention group) in which participants share their experiences with each other about stress and stressful experiences. |
| CONSCIOUS AWARENESS STRESS REDUCTION PROGRAM APPLICATION | Experimental | Conscious Awareness Based Stress Reduction (BFTSA) intervention consists of seven sessions in total and is planned to be completed in a total of seven weeks, with one session per week and each session being 45 minutes. After the results of the patients who underwent PSG are determined according to the randomization criteria and receive certain points from the sleep scale, it is planned to call the patients by phone and explain the meaning and importance of the study, the applications to be performed in the study and its duration. It is planned to have an online individual interview with patients who agree to participate in this study. Receives: Behavioral: CONSCIOUS AWARENESS STRESS REDUCTION PROGRAM APPLICATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Status
Conscious Awareness Stress Reduction Program does not affect the sleep status of patients with sleep disorders.
Measured: 11 WEEKS
Perceived Stress
Mindfulness Stress Reduction Program Affects the perceived stress level of patients with sleep disorders
Measured: 11 WEEKS
Life quality
Conscious Awareness Stress Reduction Program affects the quality of life of patients with sleep disorders.
Measured: 11 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Jul 2024
- Primary completion1 Jul 2024
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients in the Sleep ClinicStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Conscious awareness is a skill that is inherent in human nature and can be developed through training and programs. This skill will provide the individual with the opportunity to achieve inner peace, help him find ways to cope with stress and make him feel less anxiety. Internalization of the skills gained by doing conscious awareness practices is related to the participation of the individuals in the group in the process and their individual experiences in performing the practices. Although group support is effective in the acquisition of these skills, using the acquired skills in daily life is also important for the continuity of the level of conscious awareness (Mason and Hargreaves, 2001).
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536218
- Sponsor's protocol ID
- MAUN
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness Stress Reduction Program on Sleep Status, Stress and Quality of Life in Patients With Sleep Disorders: A Polysomnographic Study
- ClinicalTrials.gov ID
- NCT06536218
- Acronym / sponsor ID
- MAUN
- Conditions
- Patients in the Sleep Clinic
- Keywords
- SLEEPING DISORDER, POLYSOMNOGRAPHIC RESEARCH, CONSCIOUS AWARENESS, LIFE QUALITY, STRESS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 2 Aug 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.
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., 2019).Regarding 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, 2020).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.
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., 2019).Regarding 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, 2020).A 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Conscious awareness is a skill that is inherent in human nature and can be developed through training and programs. This skill will provide the individual with the opportunity to achieve inner peace, help him find ways to cope with stress and make him feel less anxiety. Internalization of the skills gained by doing conscious awareness practices is related to the participation of the individuals in the group in the process and their individual experiences in performing the practices. Although group support is effective in the acquisition of these skills, using the acquired skills in daily life is also important for the continuity of the level of conscious awareness (Mason and Hargreaves, 2001).
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –It is planned to conduct a one-session (60-minute), unstructured, active participation-based group application (the week when the first session is applied to the intervention group) in which participants share their experiences with each other about stress and stressful experiences. |
| CONSCIOUS AWARENESS STRESS REDUCTION PROGRAM APPLICATION | Experimental | Behavioral: CONSCIOUS AWARENESS STRESS REDUCTION PROGRAM APPLICATIONConscious Awareness Based Stress Reduction (BFTSA) intervention consists of seven sessions in total and is planned to be completed in a total of seven weeks, with one session per week and each session being 45 minutes. After the results of the patients who underwent PSG are determined according to the randomization criteria and receive certain points from the sleep scale, it is planned to call the patients by phone and explain the meaning and importance of the study, the applications to be performed in the study and its duration. It is planned to have an online individual interview with patients who agree to participate in this study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being between the ages of 18-65
Key exclusion criteria (12 listed)
- • Being diagnosed with any mental illness
- Randomization Criteria In this study, individuals;
- Age,
- Gender,
- Sleep quality scale score,
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 |
|---|---|---|
| CONSCIOUS AWARENESS STRESS REDUCTION PROGRAM APPLICATIONCONSCIOUS AWARENESS STRESS REDUCTION PROGRAM APPLICATION Conscious Awareness Based Stress Reduction (BFTSA) intervention consists of seven sessions in total and is planned to be completed in a total of seven weeks, with one session per week and each session being 45 minutes. After the results of the PSG patients are determined according to the randomization criteria, they receive certain points from the sleep scale, it is planned to call the patients by phone and explain the meaning and importance of the study, the applications to be performed in the study and its duration. It is planned to hold online individual interviews with patients who agree to participate in this study. | Behavioural | CONSCIOUS AWARENESS STRESS REDUCTION PROGRAM APPLICATION |
Primary outcome
Sleep Status
Time frame: 11 WEEKS
Conscious Awareness Stress Reduction Program does not affect the sleep status of patients with sleep disorders.
Perceived Stress
Time frame: 11 WEEKS
Mindfulness Stress Reduction Program Affects the perceived stress level of patients with sleep disorders
Life quality
Time frame: 11 WEEKS
Conscious Awareness Stress Reduction Program affects the quality of life of patients with sleep disorders.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONSCIOUS AWARENESS STRESS REDUCTION PROGRAM APPLICATION in people with Patients in the Sleep Clinic, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 2 Aug 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Sleep Status (time frame: 11 WEEKS). The study lists 3 primary outcomes in all. 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 2 Aug 2024.