EpilepsyYogaNCT04828876
The Effect of Yoga on Sleep and Quality of Life in Epilepsy Patients
A study testing Yoga practice in people with Epilepsy, run by Zülfünaz ÖZER.
Trial summary
Determining the sleep quality and quality of life of epilepsy patients and offering solutions can be effective in their success both in their professional and social lives. Therefore, in this study, it was aimed to evaluate the effectiveness of yoga therapy on sleep quality and quality of life in epilepsy patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Yoga practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2021to 30 Aug 2021
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having been diagnosed with epilepsy for at least six months,
- Does not have any disease that causes insomnia and does not use sleeping pills
- Have not participated in a similar regular exercise program in the last 6 months,
- Seizures are under control,
- Do not have a physical illness or cognitive deficiency and a psychiatric disease that prevents understanding of the education given
Who cannot join
- Epilepsy patients who do not agree to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Determining the sleep quality and quality of life of epilepsy patients and offering solutions can be effective in their success both in their professional and social lives.
Therefore, in this study, it was aimed to evaluate the effectiveness of yoga therapy on sleep quality and quality of life in epilepsy patients.
Read the detailed description
Yoga is an ancient Hindu practice with documented therapeutic effect in western countries and means perfect control of the body, emotions and mind. It consists of breathing exercises, asanas (posture), relaxation and meditation exercises. Through breathing exercises, various postures, and meditation in yoga, the connection between mind and body is established and a balanced health is assisted.
- Conditions
- Epilepsy
- Being tested
- Yoga practice
- Keywords
- yoga, Sleep, Quality life
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga practiceBehavioural
Yoga basically consists of breathing techniques, asanas (postures) and relaxation phases.
Practiced Yoga Stages; 10 min. standing breathing exercise, 10 min. breathing exercise with seated asana, 10 min. lying down breathing exercise with asana, 20 min. sitting breathing exercise, 10 min. The session will be completed in 60 minutes, including deep relaxation stages by lying down. At the end of each session, patients' feedback about yoga practice will be received.
| Study group | Role | What they receive |
|---|---|---|
| Yoga practice | Experimental | The yoga practice will be held 2 days a week for 6 weeks, a total of 12 sessions. Each session is set as one hour Receives: Behavioral: Yoga practice |
| Control group | No intervention | Routine maintenance will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Scale in Epilepsy
Quality of life
Measured: 1. week
Quality of Life Scale in Epilepsy
Quality of life
Measured: 6. week
Secondary outcomes (2)
Pittsburgh Sleep Quality Index
Sleep
Measured: 1. week
Pittsburgh Sleep Quality Index
Sleep
Measured: 6. week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start30 Jun 2021 (estimated)
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is an experimental study with pre-test and post-test control groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zülfünaz ÖZER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zülfünaz ÖZER, Istanbul Sabahattin Zaim University
- Investigators
- Zülfünaz ÖZER, PhD, Study chair, Istanbul Sabahattin Zaim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828876
- Sponsor's protocol ID
- 2020
- Acronym
- Yoga
- Status last verified
- Jun 2021
- First submitted
- 30 Mar 2021
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozer Z, Bahcecioglu Turan G, Aksoy M. The effects of yoga on dyspnea, sleep and fatigue in chronic respiratory diseases. Complement Ther Clin Pract. 2021 May;43:101306. doi: 10.1016/j.ctcp.2021.101306. Epub 2021 Jan 19.
PubMed 33545575Amaravathi E, Ramarao NH, Raghuram N, Pradhan B. Yoga-Based Postoperative Cardiac Rehabilitation Program for Improving Quality of Life and Stress Levels: Fifth-Year Follow-up through a Randomized Controlled Trial. Int J Yoga. 2018 Jan-Apr;11(1):44-52. doi: 10.4103/ijoy.IJOY_57_16.
PubMed 29343930
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga on Sleep and Quality of Life in Epilepsy Patients
- ClinicalTrials.gov ID
- NCT04828876
- Acronym / sponsor ID
- Yoga / 2020
- Conditions
- Epilepsy
- Keywords
- yoga, Sleep, Quality life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zülfünaz ÖZERUniversity, hospital or other
- Study start
- 30 Jun 2021 (estimated)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 2 Apr 2021 (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.
Determining the sleep quality and quality of life of epilepsy patients and offering solutions can be effective in their success both in their professional and social lives.
Therefore, in this study, it was aimed to evaluate the effectiveness of yoga therapy on sleep quality and quality of life in epilepsy patients.
Detailed description
Yoga is an ancient Hindu practice with documented therapeutic effect in western countries and means perfect control of the body, emotions and mind. It consists of breathing exercises, asanas (posture), relaxation and meditation exercises. Through breathing exercises, various postures, and meditation in yoga, the connection between mind and body is established and a balanced health is assisted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is an experimental study with pre-test and post-test control groups.
| Arm | Type | Receives |
|---|---|---|
| Yoga practice | Experimental | Behavioral: Yoga practiceThe yoga practice will be held 2 days a week for 6 weeks, a total of 12 sessions. Each session is set as one hour |
| Control group | No intervention | –Routine maintenance will be applied |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Having been diagnosed with epilepsy for at least six months,
- Does not have any disease that causes insomnia and does not use sleeping pills
- Have not participated in a similar regular exercise program in the last 6 months,
- Seizures are under control,
- Do not have a physical illness or cognitive deficiency and a psychiatric disease that prevents understanding of the education given
Key exclusion criteria (1 listed)
- Epilepsy patients who do not agree to participate in the study
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 |
|---|---|---|
| Yoga practiceYoga basically consists of breathing techniques, asanas (postures) and relaxation phases. Practiced Yoga Stages; 10 min. standing breathing exercise, 10 min. breathing exercise with seated asana, 10 min. lying down breathing exercise with asana, 20 min. sitting breathing exercise, 10 min. The session will be completed in 60 minutes, including deep relaxation stages by lying down. At the end of each session, patients' feedback about yoga practice will be received. | Behavioural | Yoga practice |
Primary outcome
Quality of Life Scale in Epilepsy
Time frame: 1. week
Quality of life
Quality of Life Scale in Epilepsy
Time frame: 6. week
Quality of life
2 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: 1. week
Pittsburgh Sleep Quality Index
Time frame: 6. week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Background: PubMed 33545575Ozer Z, Bahcecioglu Turan G, Aksoy M. The effects of yoga on dyspnea, sleep and fatigue in chronic respiratory diseases. Complement Ther Clin Pract. 2021 May;43:101306. doi: 10.1016/j.ctcp.2021.101306. Epub 2021 Jan 19.
- Results publication: PubMed 29343930Amaravathi E, Ramarao NH, Raghuram N, Pradhan B. Yoga-Based Postoperative Cardiac Rehabilitation Program for Improving Quality of Life and Stress Levels: Fifth-Year Follow-up through a Randomized Controlled Trial. Int J Yoga. 2018 Jan-Apr;11(1):44-52. doi: 10.4103/ijoy.IJOY_57_16.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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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.
Zülfünaz ÖZER, PhD study chair
Istanbul Sabahattin Zaim University
Questions about this trial
What is this clinical trial studying?
A study testing Yoga practice in people with Epilepsy, run by Zülfünaz ÖZER.
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 5 inclusion and 1 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 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Zülfünaz ÖZER, Phd (+905379537007, zulfinazozer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Scale in Epilepsy (time frame: 1. week). The study lists 2 primary outcomes in all. 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 NCT04828876, which also lists 2 linked publications.
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 15 Jun 2021.