COVID-19NCT05139979
Yogic Breathing and Guided Meditation for Long Covid Symptoms
A study testing Breathing and Wellness Webinar and Routine Daily Activity in people with COVID-19 and Stress, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This study aims to assess the impact of brief digitally delivered breathing practice and guided meditation on post-Covid physical and mental symptoms in Long Covid Patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Stress, Shortness of Breath
- What is being tested?
- Breathing and Wellness Webinar and Routine Daily Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 7 Feb 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years
- Interested in attending the online Breathing and Wellness webinar.
- Laboratory-confirmed (PCR) history of Covid-19 infection.
- Long Covid condition diagnosis by a physician.
- Able to read and comprehend English.
- Currently residing in the United States.
Who cannot join
- ● Any medically limiting diagnosis that prevents a patient from doing the intervention or completing the assessments as determined by the PI such as severe Major Depression (under medication), Schizophrenia, Bipolar disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Centre
Boston, Massachusetts, 02215
About this study
This study aims to assess the impact of brief digitally delivered breathing practice and guided meditation on post-Covid physical and mental symptoms in Long Covid Patients.
Read the detailed description
Long Covid symptoms can last weeks to months after the initial Covid infection or can appear weeks after. It can occur in those with mild disease or asymptomatic patients. Most commonly reported symptoms of Long Covid are:
- Tiredness or fatigue
- Difficulty thinking or concentrating (sometimes referred to as "brain fog")
- Headache
- Loss of smell or taste
- Dizziness on standing
- Fast-beating or pounding heart (also known as heart palpitations)
- Chest pain
- Difficulty breathing or shortness of breath
- Cough
- Joint or muscle pain
- Depression or anxiety
- Fever
- Symptoms that get worse after physical or mental activities
To this date, nearly 180 million people have been infected with Covid19 and over 3 million have lost their lives worldwide. The increasing prevalence of patients with Long Covid symptoms and the lack of effective solutions to address their condition, creates an urgent need for non-pharmacological interventions that are effective and scalable and can be delivered online to accommodate for the limitations due to the Covid pandemic.
Yogic Breathing and Meditation techniques have been shown to have various health benefits including improving pulmonary function and mental health. Prominent health institutions are recommending breathing exercise to their Covid patients to assist their respiratory recovery9. Meditation and breathing is also shown to help with Covid related stress and anxiety.
This study is a waitlisted randomized controlled trial conducted in 2 phases:
Phase 1: If participants are in the intervention group, they will be asked to learn and practices two Yogic Breathing practices (Simha Kriya and Nadi Shuddhi) and a guided meditation (Isha Kriya) for 3 weeks They will be asked to complete a set of questionnaires at baseline and the end of each week. Participants in the waitlisted control group will be asked to perform their regular daily routine as they wait to be enrolled into the intervention at the end of 3 weeks. The waitlisted control group will also be recruited for semi-structured individual interviews during this time.
Phase 2: The waitlisted control group will begin the intervention at week 3 and continue until week 6. They will be asked to continue completing the questionnaires at the end of each week. The intervention group will be asked to complete a final follow-up questionnaire at the end of week 6. The intervention group will also be recruited for semi-structured individual interviews during this time.
Focus group discussions with both the intervention and control groups are conducted at the end of the study to collect general information about the participant's general experience with the current study and what matters to them as a Long COVID patients.
- Conditions
- COVID-19, Stress, Shortness of Breath
- Being tested
- Breathing and Wellness Webinar, Routine Daily Activity
- Keywords
- Long COVID-19, Mental health, Anxiety, Stress, Breathing, Meditation, Yoga, Isha Kriya
- Medical subject headings
- COVID-19, Dyspnea, Post-Acute COVID-19 Syndrome, Psychological Well-Being, Anxiety Disorders, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing and Wellness WebinarBehavioural
Simha Kriya : a 3-minute energizing breathing practice to expand lung capacity and improve immunity, to be practiced twice daily.
Nadi Shuddhi - a gentle 4-minute breathing practice for creating mental balance and relaxation, to be practiced for a minimum of 4 minutes daily.
Isha Kriya - a 15-minute guided meditation that incorporates the breath and the awareness to create mental clarity and health, to be practiced at least once (ideally twice) daily.
Routine Daily ActivityOther
Participants in the control group are asked to perform routine daily activities until enrolled into the intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| Webinar-Based Intervention | Experimental | Breathing and Wellness Webinar: two yogic breathing practices (Simha Kriya and Naddi Shuddi) and a guided meditation (Isha Kriya). Receives: Behavioral: Breathing and Wellness Webinar |
| Control | Placebo comparator | This group will be asked to wait for 3 weeks before being introduced to the Breathing and Wellness Webinar intervention which includes two yogic breathing practices (Simha Kriya and Naddi Shuddi) and a guided meditation (Isha Kriya). Receives: Other: Routine Daily Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
The weekly compliance questionnaire is a tool which helps the participants to keep track of their activities each week. This enables the study team to measure compliance and protocol adherence by the participants by collecting information on their routine activity practiced and its frequency. This will be reported in "Number of days an intervention was practiced in a week". Compliance is defined as completing 60% (4 days/week or more) of the activity that is prescribed in the protocol. This means that at least one of the three practices (Isha Kriya, Nadi Shuddhi, or Simha Kriya) must be completed once a day for a minimum of four days.
Measured: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Secondary outcomes (6)
Perceived Stress Scale (PSS)
PSS is a 10-question validated instrument that assesses stress. Participants are asked to rate on a scale of 0 (never) to 4 (very often) how often they agree with various statements.
Measured: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Profile of Mood States (POMS)
This is a short validated survey used to measure six different dimensions of mood swings over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment. A five-point scale ranging from "not at all" to "extremely" is administered and scores for each dimension contributes to calculation of positive and negative subscales in conjunction to total mood disturbance.
Measured: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Quality of Life Survey (SF12)
SF12 is a validated self-reported measure of the impact of health on everyday quality of life. It evaluates domains of physical activities, social activities, usual role activities, bodily pain, general mental health, vitality and general health perception.
Measured: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Multidimensional Dyspnea Profile (MDP)
MDP is a validated scale to assess the overall breathing discomfort, sensory qualities and emotional responses using 8 questions. It is not intended for a particular activity and can be used during rest, activity or during clinical care. For assessing Long Covid patients, the first three parts (breathing discomfort and sensory qualities) are commonly used.
Measured: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Somatic Symptom Scale 8 Items (SS8)
SS8 is a validated brief questionnaire to assess common somatic symptoms including pain, shortness of breath, dizziness, fatigue and trouble sleeping. Participants are asked to rate on a scale of 0 (not at all) to 4 (very much) how often they agree with various statements. Items from each of the 8 questions are then summed to create a total perceived stress score.
Measured: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Qualitative Assessments
The semi-structured individual interviews will allow us to gain rich, descriptive information about the participant's experience with the long COVID symptoms, treating physicians, and the effect of the provided practices on their symptoms. The focus group interviews will be semi-structured to ensure a systematic and flexible approach to data collection, allowing us to gain rich information about the participant's general experience with the current study and what matters to them as a Long COVID patients.
The interviews will cover the following main topics: (1) Perceptions of the participants on their long COVID symptoms, (2) Perceptions of the participants on their treating physicians (3) the effect of the provided meditation practices on their long COVID symptoms (4) and what matters to the Long COVID patients as well as their general experience as participants in the current study.
Measured: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start15 Sep 2021
- Primary completion7 Feb 2024
- Study completion7 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Crossover
- Model description
- Upon enrollment and randomization, the intervention group will be followed weekly for 3 weeks as well as on week 6. The waitlisted control group will be followed for 3 weeks as controls and will then learn the intervention and be followed for additional 3 weeks (total of 6 weeks).
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balachundhar Subramaniam, Beth Israel Deaconess Medical Center
- Investigators
- Balachundar Subramaniam, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139979
- Sponsor's protocol ID
- 2021P000552
- Status last verified
- Jun 2024
- First submitted
- 23 Sep 2021
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Greenhalgh T, Knight M, A'Court C, Buxton M, Husain L. Management of post-acute covid-19 in primary care. BMJ. 2020 Aug 11;370:m3026. doi: 10.1136/bmj.m3026. No abstract available.
PubMed 32784198Taquet M, Geddes JR, Husain M, Luciano S, Harrison PJ. 6-month neurological and psychiatric outcomes in 236 379 survivors of COVID-19: a retrospective cohort study using electronic health records. Lancet Psychiatry. 2021 May;8(5):416-427. doi: 10.1016/S2215-0366(21)00084-5. Epub 2021 Apr 6.
PubMed 33836148Abel AN, Lloyd LK, Williams JS. The effects of regular yoga practice on pulmonary function in healthy individuals: a literature review. J Altern Complement Med. 2013 Mar;19(3):185-90. doi: 10.1089/acm.2011.0516. Epub 2012 Sep 14.
PubMed 22978245Budhi RB, Payghan S, Deepeshwar S. Changes in Lung Function Measures Following Bhastrika Pranayama (Bellows Breath) and Running in Healthy Individuals. Int J Yoga. 2019 Sep-Dec;12(3):233-239. doi: 10.4103/ijoy.IJOY_43_18.
PubMed 31543632Rangasamy V, Thampi Susheela A, Mueller A, F H Chang T, Sadhasivam S, Subramaniam B. The effect of a one-time 15-minute guided meditation (Isha Kriya) on stress and mood disturbances among operating room professionals: a prospective interventional pilot study. F1000Res. 2019 Mar 26;8:335. doi: 10.12688/f1000research.18446.1. eCollection 2019.
PubMed 32665843Maric V, Mishra J, Ramanathan DS. Using Mind-Body Medicine to Reduce the Long-Term Health Impacts of COVID-Specific Chronic Stress. Front Psychiatry. 2021 Feb 22;12:585952. doi: 10.3389/fpsyt.2021.585952. eCollection 2021. No abstract available.
PubMed 33692706Rain M, Subramaniam B, Avti P, Mahajan P, Anand A. Can Yogic Breathing Techniques Like Simha Kriya and Isha Kriya Regulate COVID-19-Related Stress? Front Psychol. 2021 Apr 15;12:635816. doi: 10.3389/fpsyg.2021.635816. eCollection 2021.
PubMed 33935886Narayanan S, Tennison J, Cohen L, Urso C, Subramaniam B, Bruera E. Yoga-Based Breathing Techniques for Health Care Workers During COVID-19 Pandemic: Interests, Feasibility, and Acceptance. J Altern Complement Med. 2021 Aug;27(8):706-709. doi: 10.1089/acm.2020.0536. Epub 2021 Apr 9.
PubMed 33835830
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yogic Breathing and Guided Meditation for Long Covid Symptoms
- ClinicalTrials.gov ID
- NCT05139979
- Acronym / sponsor ID
- 2021P000552
- Conditions
- COVID-19, Stress, Shortness of Breath
- Keywords
- Long COVID-19, Mental health, Anxiety, Stress, Breathing, Meditation, Yoga, Isha Kriya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 7 Feb 2024 (actual)
- First posted
- 1 Dec 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.
This study aims to assess the impact of brief digitally delivered breathing practice and guided meditation on post-Covid physical and mental symptoms in Long Covid Patients.
Detailed description
Long Covid symptoms can last weeks to months after the initial Covid infection or can appear weeks after. It can occur in those with mild disease or asymptomatic patients. Most commonly reported symptoms of Long Covid are:
- Tiredness or fatigue
- Difficulty thinking or concentrating (sometimes referred to as "brain fog")
- Headache
- Loss of smell or taste
- Dizziness on standing
- Fast-beating or pounding heart (also known as heart palpitations)
- Chest pain
- Difficulty breathing or shortness of breath
- Cough
- Joint or muscle pain
- Depression or anxiety
- Fever
- Symptoms that get worse after physical or mental activities
To this date, nearly 180 million people have been infected with Covid19 and over 3 million have lost their lives worldwide. The increasing prevalence of patients with Long Covid symptoms and the lack of effective solutions to address their condition, creates an urgent need for non-pharmacological interventions that are effective and scalable and can be delivered online to accommodate for the limitations due to the Covid pandemic.
Yogic Breathing and Meditation techniques have been shown to have various health benefits including improving pulmonary function and mental health. Prominent health institutions are recommending breathing exercise to their Covid patients to assist their respiratory recovery9. Meditation and breathing is also shown to help with Covid related stress and anxiety.
This study is a waitlisted randomized controlled trial conducted in 2 phases:
Phase 1: If participants are in the intervention group, they will be asked to learn and practices two Yogic Breathing practices (Simha Kriya and Nadi Shuddhi) and a guided meditation (Isha Kriya) for 3 weeks They will be asked to complete a set of questionnaires at baseline and the end of each week. Participants in the waitlisted control group will be asked to perform their regular daily routine as they wait to be enrolled into the intervention at the end of 3 weeks. The waitlisted control group will also be recruited for semi-structured individual interviews during this time.
Phase 2: The waitlisted control group will begin the intervention at week 3 and continue until week 6. They will be asked to continue completing the questionnaires at the end of each week. The intervention group will be asked to complete a final follow-up questionnaire at the end of week 6. The intervention group will also be recruited for semi-structured individual interviews during this time.
Focus group discussions with both the intervention and control groups are conducted at the end of the study to collect general information about the participant's general experience with the current study and what matters to them as a Long COVID patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Upon enrollment and randomization, the intervention group will be followed weekly for 3 weeks as well as on week 6. The waitlisted control group will be followed for 3 weeks as controls and will then learn the intervention and be followed for additional 3 weeks (total of 6 weeks).
| Arm | Type | Receives |
|---|---|---|
| Webinar-Based Intervention | Experimental | Behavioral: Breathing and Wellness WebinarBreathing and Wellness Webinar: two yogic breathing practices (Simha Kriya and Naddi Shuddi) and a guided meditation (Isha Kriya). |
| Control | Placebo comparator | Other: Routine Daily ActivityThis group will be asked to wait for 3 weeks before being introduced to the Breathing and Wellness Webinar intervention which includes two yogic breathing practices (Simha Kriya and Naddi Shuddi) and a guided meditation (Isha Kriya). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 70 years
- Interested in attending the online Breathing and Wellness webinar.
- Laboratory-confirmed (PCR) history of Covid-19 infection.
- Long Covid condition diagnosis by a physician.
- Able to read and comprehend English.
Key exclusion criteria (1 listed)
- ● Any medically limiting diagnosis that prevents a patient from doing the intervention or completing the assessments as determined by the PI such as severe Major Depression (under medication), Schizophrenia, Bipolar disorder.
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 and Wellness WebinarSimha Kriya : a 3-minute energizing breathing practice to expand lung capacity and improve immunity, to be practiced twice daily. Nadi Shuddhi - a gentle 4-minute breathing practice for creating mental balance and relaxation, to be practiced for a minimum of 4 minutes daily. Isha Kriya - a 15-minute guided meditation that incorporates the breath and the awareness to create mental clarity and health, to be practiced at least once (ideally twice) daily. | Behavioural | Webinar-Based Intervention |
| Routine Daily ActivityParticipants in the control group are asked to perform routine daily activities until enrolled into the intervention arm. | Other | Control |
Primary outcome
Compliance
Time frame: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
The weekly compliance questionnaire is a tool which helps the participants to keep track of their activities each week. This enables the study team to measure compliance and protocol adherence by the participants by collecting information on their routine activity practiced and its frequency. This will be reported in "Number of days an intervention was practiced in a week". Compliance is defined as completing 60% (4 days/week or more) of the activity that is prescribed in the protocol. This means that at least one of the three practices (Isha Kriya, Nadi Shuddhi, or Simha Kriya) must be completed once a day for a minimum of four days.
6 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Profile of Mood States (POMS)
Time frame: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Quality of Life Survey (SF12)
Time frame: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Multidimensional Dyspnea Profile (MDP)
Time frame: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Somatic Symptom Scale 8 Items (SS8)
Time frame: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Qualitative Assessments
Time frame: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 32784198Greenhalgh T, Knight M, A'Court C, Buxton M, Husain L. Management of post-acute covid-19 in primary care. BMJ. 2020 Aug 11;370:m3026. doi: 10.1136/bmj.m3026. No abstract available.
- Background: PubMed 33836148Taquet M, Geddes JR, Husain M, Luciano S, Harrison PJ. 6-month neurological and psychiatric outcomes in 236 379 survivors of COVID-19: a retrospective cohort study using electronic health records. Lancet Psychiatry. 2021 May;8(5):416-427. doi: 10.1016/S2215-0366(21)00084-5. Epub 2021 Apr 6.
- Background: PubMed 22978245Abel AN, Lloyd LK, Williams JS. The effects of regular yoga practice on pulmonary function in healthy individuals: a literature review. J Altern Complement Med. 2013 Mar;19(3):185-90. doi: 10.1089/acm.2011.0516. Epub 2012 Sep 14.
- Background: PubMed 31543632Budhi RB, Payghan S, Deepeshwar S. Changes in Lung Function Measures Following Bhastrika Pranayama (Bellows Breath) and Running in Healthy Individuals. Int J Yoga. 2019 Sep-Dec;12(3):233-239. doi: 10.4103/ijoy.IJOY_43_18.
- Background: PubMed 32665843Rangasamy V, Thampi Susheela A, Mueller A, F H Chang T, Sadhasivam S, Subramaniam B. The effect of a one-time 15-minute guided meditation (Isha Kriya) on stress and mood disturbances among operating room professionals: a prospective interventional pilot study. F1000Res. 2019 Mar 26;8:335. doi: 10.12688/f1000research.18446.1. eCollection 2019.
- Background: PubMed 33692706Maric V, Mishra J, Ramanathan DS. Using Mind-Body Medicine to Reduce the Long-Term Health Impacts of COVID-Specific Chronic Stress. Front Psychiatry. 2021 Feb 22;12:585952. doi: 10.3389/fpsyt.2021.585952. eCollection 2021. No abstract available.
- Background: PubMed 33935886Rain M, Subramaniam B, Avti P, Mahajan P, Anand A. Can Yogic Breathing Techniques Like Simha Kriya and Isha Kriya Regulate COVID-19-Related Stress? Front Psychol. 2021 Apr 15;12:635816. doi: 10.3389/fpsyg.2021.635816. eCollection 2021.
- Background: PubMed 33835830Narayanan S, Tennison J, Cohen L, Urso C, Subramaniam B, Bruera E. Yoga-Based Breathing Techniques for Health Care Workers During COVID-19 Pandemic: Interests, Feasibility, and Acceptance. J Altern Complement Med. 2021 Aug;27(8):706-709. doi: 10.1089/acm.2020.0536. Epub 2021 Apr 9.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Balachundar Subramaniam, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
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 and Wellness Webinar and Routine Daily Activity in people with COVID-19 and Stress, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 6 Feb 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compliance (time frame: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.). 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 NCT05139979, which also lists 8 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 6 Feb 2025.