GlaucomaNCT05960513
Impact of Breathing Exercises and Meditation on Improving Quality of Life in Glaucoma Patients
A study testing Breathing Exercises followed by Meditation in people with Glaucoma and Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Glaucoma is a chronic disease that causes loss of vision and potentially blindness as a result of optic nerve damage, often due to increased intraocular pressure. Glaucoma is currently the leading cause of irreversible blindness worldwide.1 In 2020, 4.1 million and 3.6 million adults over the age of 50 suffered from… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Glaucoma, Depression, Anxiety
- What is being tested?
- Breathing Exercises followed by Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2023to 1 Nov 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with glaucoma.
- Patients aged 40-65.
- Being able to provide valid informed consent to participate in the research study.
- Being able to read and understand English.
- Having no significant self-reported or physician-diagnosed mental health disorder.
- Independent access to a computer to participate in virtual sessions.
- Must be able to sit comfortably for 30-35 minutes without any major pain or discomfort, can hear well enough to follow verbal instructions when the eyes are closed, and be in good general physical health.
Who cannot join
- Inability to provide valid informed consent.
- Significant communication barriers or lack of English proficiency that prevents participants from completing the questionnaires.
- Severe depression as confirmed by a CES-D ≥ 24.
- Having a lifetime diagnosis of self-reported other serious mental disorders, including bipolar I or II disorder, primary psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder).
- Self-reported substance abuse or dependence within the past 3 months.
- Having acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.
- Having irreversible vision loss that prevents one from completing the questionnaires.
- Participation in a study involving similar techniques.
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Hospital, Ivey Eye Institute
London, Ontario, N6G0H8
Scott McKinnon, 519 685-8500 ext. 58250, scott.mckinnon@sjhc.london.on.ca
Cindy Hutnik, MD
About this study
Official title: Impact of Breathing Exercises and Meditation on Improving Quality of Life in Glaucoma Patients: An Electronic Pilot Feasibility Study
Glaucoma is a chronic disease that causes loss of vision and potentially blindness as a result of optic nerve damage, often due to increased intraocular pressure. Glaucoma is currently the leading cause of irreversible blindness worldwide.1 In 2020, 4.1 million and 3.6 million adults over the age of 50 suffered from mild to severe glaucoma-induced visual impairment and blindness, respectively.1 However, these figures are likely underestimated since glaucoma can remain asymptomatic until later stages in disease progression.2 The relaxation response evoked by mind-body interventions, such as breathing exercises and meditation, is known to reduce stress and improve quality of life (QOL). In a recent study, mindfulness-based meditation was found to reduce intraocular pressure and improve QOL in patients with glaucoma.3 A feasibility study will be conducted using a mixed-method design to assess the feasibility of the online delivery of an intervention titled Breathing Exercises followed by Meditation for potentially enhancing the QOL and mental health of glaucoma patients. Upon recruitment, participants will undergo blocked randomization to either the intervention arm or usual care arm, stratified by sex. Participants in each arm will complete online questionnaires at baseline and after 12 weeks to collect data on health-related quality of life (HRQOL), depression symptoms, anxiety, and sleep quality using REDCap, an electronic data capturing system provided by Lawson Health Research Institute (LHRI). Our study can help to assess the feasibility of conducting a pilot study on breathing exercises followed by meditation to assess its effects in a sample of patients with glaucoma.
- Conditions
- Glaucoma, Depression, Anxiety, Quality of Life, Sleep Disorder
- Being tested
- Breathing Exercises followed by Meditation
- Keywords
- Health-related Quality of Life, Glaucoma, COVID-19, Breathing, Meditation
- Medical subject headings
- Glaucoma, Depression, Anxiety Disorders, Sleep Wake Disorders, COVID-19, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing Exercises followed by MeditationBehavioural
Breathing exercises and Meditation taught by Prasanna Wellness, a non-profit organization, helps dissolve stress and create a proper system in the mind. These breathing exercises include slow deep breaths and rapid breaths and are followed by meditation. Meditation is a guided meditation that helps to eliminate stress and establish an apposite system in the mind, therefore inducing physiological and mental relaxation whilst the eyes are shut. The proposed duration and frequency of the follow-up will be 60-minutes weekly for 11 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Breathing Exercises followed by Meditation | Experimental | Breathing exercises and Meditation taught by Prasanna Wellness, a non-profit organization, helps dissolve stress and create a proper system in the mind. These breathing exercises include slow deep breaths and rapid breaths and are followed by meditation. Participants will receive three weekly online instructions (90 minutes each) by trained instructors in addition to standard care. Weekly 60 minutes follow-ups will include 10 minutes of breathing exercises followed by 33 minutes of guided meditation practice, and then focus on participants' experiences with breathing exercise followed by meditation during the week, additional observations, and a review of relevant knowledge to support their home practice. Receives: Behavioral: Breathing Exercises followed by Meditation |
| No Intervention | No intervention | The usual standard of care for patients with glaucoma includes starting them on first line of drugs. Participants will be initiated and maintained on appropriate dosages of such medications as part of standard of care. The usual standard of care also includes an ophthalmic examination measuring best-corrected Snellen VA and pinhole acuities and a follow-up visit once a year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in health-related quality of life (HRQoL)
HRQoL is an essential measure of quality of life related to health; it helps physician identify hidden morbidity in clinical care as well as improves patient-physician communications. HRQoL will be measured using time trade-off questionnaire
Measured: Baseline visit, Week 1, Week 3, Week 6, Week 12
Change in Depression
Depression is a feeling of severe despondency and dejection. Depression will be measured using the Center for Epidemiological Studies - Depression (CES-D) score.
Measured: Baseline visit, Week 1, Week 3, Week 6, Week 12
Change in Anxiety
Anxiety will be measured using Hospital Anxiety and Depression Scale - Anxiety (HADS-A) subscale
Measured: Baseline visit, Week 1, Week 3, Week 6, Week 12
Change in Sleep quality
Sleep quality as measured using the Pittsburgh Sleep Quality Index (PSQI) scores.
Measured: Baseline visit, Week 1, Week 3, Week 6, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monali Malvankar, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960513
- Sponsor's protocol ID
- 122096
- Status last verified
- Oct 2023
- First submitted
- 14 Jul 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) collected in this study will not be available to other researchers (e.g., outside the primary research group). Since the primary research group has the necessary expertise to analyze the data and do not need any outside help.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Breathing Exercises and Meditation on Improving Quality of Life in Glaucoma Patients: An Electronic Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT05960513
- Acronym / sponsor ID
- 122096
- Conditions
- Glaucoma, Depression, Anxiety, Quality of Life, Sleep Disorder
- Keywords
- Health-related Quality of Life, Glaucoma, COVID-19, Breathing, Meditation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 25 Jul 2023 (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.
Glaucoma is a chronic disease that causes loss of vision and potentially blindness as a result of optic nerve damage, often due to increased intraocular pressure. Glaucoma is currently the leading cause of irreversible blindness worldwide.1 In 2020, 4.1 million and 3.6 million adults over the age of 50 suffered from mild to severe glaucoma-induced visual impairment and blindness, respectively.1 However, these figures are likely underestimated since glaucoma can remain asymptomatic until later stages in disease progression.2 The relaxation response evoked by mind-body interventions, such as breathing exercises and meditation, is known to reduce stress and improve quality of life (QOL). In a recent study, mindfulness-based meditation was found to reduce intraocular pressure and improve QOL in patients with glaucoma.3 A feasibility study will be conducted using a mixed-method design to assess the feasibility of the online delivery of an intervention titled Breathing Exercises followed by Meditation for potentially enhancing the QOL and mental health of glaucoma patients. Upon recruitment, participants will undergo blocked randomization to either the intervention arm or usual care arm, stratified by sex. Participants in each arm will complete online questionnaires at baseline and after 12 weeks to collect data on health-related quality of life (HRQOL), depression symptoms, anxiety, and sleep quality using REDCap, an electronic data capturing system provided by Lawson Health Research Institute (LHRI). Our study can help to assess the feasibility of conducting a pilot study on breathing exercises followed by meditation to assess its effects in a sample of patients with glaucoma.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercises followed by Meditation | Experimental | Behavioral: Breathing Exercises followed by MeditationBreathing exercises and Meditation taught by Prasanna Wellness, a non-profit organization, helps dissolve stress and create a proper system in the mind. These breathing exercises include slow deep breaths and rapid breaths and are followed by meditation. Participants will receive three weekly online instructions (90 minutes each) by trained instructors in addition to standard care. Weekly 60 minutes follow-ups will include 10 minutes of breathing exercises followed by 33 minutes of guided meditation practice, and then focus on participants' experiences with breathing exercise followed by meditation during the week, additional observations, and a review of relevant knowledge to support their home practice. |
| No Intervention | No intervention | –The usual standard of care for patients with glaucoma includes starting them on first line of drugs. Participants will be initiated and maintained on appropriate dosages of such medications as part of standard of care. The usual standard of care also includes an ophthalmic examination measuring best-corrected Snellen VA and pinhole acuities and a follow-up visit once a year. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients diagnosed with glaucoma.
- Patients aged 40-65.
- Being able to provide valid informed consent to participate in the research study.
- Being able to read and understand English.
- Having no significant self-reported or physician-diagnosed mental health disorder.
Key exclusion criteria (8 listed)
- Inability to provide valid informed consent.
- Significant communication barriers or lack of English proficiency that prevents participants from completing the questionnaires.
- Severe depression as confirmed by a CES-D ≥ 24.
- Having a lifetime diagnosis of self-reported other serious mental disorders, including bipolar I or II disorder, primary psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder).
- Self-reported substance abuse or dependence within the past 3 months.
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 |
|---|---|---|
| Breathing Exercises followed by MeditationBreathing exercises and Meditation taught by Prasanna Wellness, a non-profit organization, helps dissolve stress and create a proper system in the mind. These breathing exercises include slow deep breaths and rapid breaths and are followed by meditation. Meditation is a guided meditation that helps to eliminate stress and establish an apposite system in the mind, therefore inducing physiological and mental relaxation whilst the eyes are shut. The proposed duration and frequency of the follow-up will be 60-minutes weekly for 11 weeks. | Behavioural | Breathing Exercises followed by Meditation |
Primary outcome
Change in health-related quality of life (HRQoL)
Time frame: Baseline visit, Week 1, Week 3, Week 6, Week 12
HRQoL is an essential measure of quality of life related to health; it helps physician identify hidden morbidity in clinical care as well as improves patient-physician communications. HRQoL will be measured using time trade-off questionnaire
Change in Depression
Time frame: Baseline visit, Week 1, Week 3, Week 6, Week 12
Depression is a feeling of severe despondency and dejection. Depression will be measured using the Center for Epidemiological Studies - Depression (CES-D) score.
Change in Anxiety
Time frame: Baseline visit, Week 1, Week 3, Week 6, Week 12
Anxiety will be measured using Hospital Anxiety and Depression Scale - Anxiety (HADS-A) subscale
Change in Sleep quality
Time frame: Baseline visit, Week 1, Week 3, Week 6, Week 12
Sleep quality as measured using the Pittsburgh Sleep Quality Index (PSQI) scores.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) collected in this study will not be available to other researchers (e.g., outside the primary research group). Since the primary research group has the necessary expertise to analyze the data and do not need any outside help.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Exercises followed by Meditation in people with Glaucoma and Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 7 inclusion and 8 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 18 Oct 2023. 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 Canada. 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?
Contact Monali Malvankar, PhD (5192815260 ext. 61288, monali.malvankar@schulich.uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health-related quality of life (HRQoL) (time frame: Baseline visit, Week 1, Week 3, Week 6, Week 12). The study lists 4 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 18 Oct 2023.