HealthyNCT05876637
Effects of Left Nostril Breathing in Young Females Having Cardiovascular Hyper Reactivity to Cold Pressor Test.
A study testing Left Nostril Breathing and Conventional in people with Healthy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The purpose of this study is to evaluate the effects of left nostril breathing in young females having cardiovascular hyper reactivity to cold pressor test.Although,limited literature exist regarding hyper reactivity towards stress induced test in our youth and its effective and easy treatment in the form of left… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Healthy
- What is being tested?
- Left Nostril Breathing and Conventional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 15 Dec 2023
- 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 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participants falling in the following category would be recruited into the study:
- Females Age (18-25) years
- Participants who show hyper reactivity to Cold pressor test (i.e subjects showing 25mmHg increase in systolic blood pressure along with 20mmHg increase in diastolic blood pressure)
- Consenting participants.
Who cannot join
- The participants in the following category would be excluded from the study:
- Participants on antihypertensive drugs.
- Participants who are diagnosed with any cardiovascular, renal, hepatic or metabolic disease.
- Participants having malignant tumor.
- Participants with nasal blockages, polyps ,Raynaud phenomena
- Females during menstrual cycle, pregnancy or on oral contraceptives.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Women Instritute of Rehabilitation Sciences, Jinnah College of Nursing
Abbottābād, KPK, 22010
About this study
The purpose of this study is to evaluate the effects of left nostril breathing in young females having cardiovascular hyper reactivity to cold pressor test.Although,limited literature exist regarding hyper reactivity towards stress induced test in our youth and its effective and easy treatment in the form of left nostril breathing which could proves to be beneficial for our youth.
Read the detailed description
The Cold Pressor Test (CPT) was introduced as a standard incentive for studying the vasomotor response (Hines and Brown 1932). Hyper-reactors were the subjects in his study who responded more strongly to CPT, Participants who show hyper reactivity to Cold pressor test (i.e. subjects showing 25 mmHg increase in systolic blood pressure along with 20 mmHg increase in diastolic blood pressure).They proposed that these hyper reactive could be candidates for hypertension in the future. Increased occurrence of these diseases could be attributed to an asymmetry in sympathetic and parasympathetic stimulation. Control or adaptation of breathing or breathing workouts i-e yoga are thought to be beneficial in the treatment of such disease. Although Yoga techniques proven to be effective in treating stress related disorders but it is time consuming and young population because of their busy routine couldn't be able to take out time for their health related issues. This study introduces very simple exercise in the form of left nostril breathing which decreases sympathetic activity and increases parasympathetic activity. It is inversely proportional to stress induced response of the body, it is very easy to perform and can be done at any time, and if found significantly effective for stress disorder ,it could be used in daily routine by our youth to get themselves prevented from major risk factors of CVD's particularly hypertension. This study will identify participants with a high potential risk of developing hypertension in the future by administering Cold pressor test, additionally the effects of left nostril breathing intervention on hyper reactive participants would be observed and if found significant, it would be a major breakthrough in primary prevention of hypertension.
- Conditions
- Healthy
- Being tested
- Left Nostril Breathing, Conventional
- Keywords
- blood pressure, cold pressor test, heart rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Nostril BreathingOther
The participants which will show cardiovascular hyper reactivity towards CPT will be divided into 2 groups having 30 participants in each group. Experimental group will receive Left Nostril Breathing(slow, deep breath taken through your left nostril while closing your right nostril with your right thumb. Then just as gently exhale long, slowly, and completely through the left nostril, just as gently. It will be done while sitting) for 10 minutes twice a day for the duration of 12 weeks. Follow up will be taken through administration Cold pressor test after every 4,8 and 12 weeks.
ConventionalOther
30 participants will be recruited in conventional group which will receive simple deep breathing exercises of 3 sessions per week for the duration of 12 weeks.Follow up will be taken after every 4,8 and 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Left Nostril Breathing | Experimental | The intervention protocol include healthy young females age 18-25 years.. All baseline measurements will be taken , Afterwards, the Cold pressor test would be performed for 1 minutes to induce acute stress while the BP would be monitored for every 30 seconds. At the end of the test, again the BP would be monitored. Out of all the recordings, the BP measuring the highest value would be recorded as final. We will then subtract the normal resting BP by highest value of the recording for each participant. Change in BP of systolic by 25mmHg and diastolic by 20mmHg will be considered hyper reactive. Then the hyper reactive subjects will be divided into two groups. Experimental group will receive left nostril breathing. CPT will be performed again at 4, 8 and 12 weeks to monitor the BP, heart rate and Spo2 likewise to check for any decline in sympathetic activity. Receives: Other: Left Nostril Breathing |
| Conventional | Active comparator | The conventional protocol include healthy young females age 18-25 years. All baseline measurements will be taken, Afterwards, the Cold pressor test would be performed for 1 minutes to induce acute stress while the BP would be monitored for every 30 seconds. At the end of the test, again the BP would be monitored. Out of all the recordings, the BP measuring the highest value would be recorded as final. We will then subtract the normal resting BP by highest value of the recording for each participant. Change in BP of systolic by 25mmHg and diastolic by 20mmHg will be considered hyper reactive. Then the hyper reactive subjects will be divided into two groups Group A(Experimental) and Group B(Conventional). Controlled group will receive simple deep breathing exercises ,3 sessions per week for 12 weeks. CPT will be performed again at 4, 8 and 12 weeks to monitor the BP, heart rate and Spo2 likewise to check for any decline in sympathetic activity. Receives: Other: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold pressor test
Cold pressor test will be conducted on participants to measure cardio vascular hyper reactivity to stress induce test.
Measured: After 4 weeks
Blood pressure
Mercury sphygmomanometer will be used to measure blood pressure of participants
Measured: After 4 weeks
Heart Rate
Pulse oximeter will be applied to the participant to measure their Heart rate.
Measured: After 4 weeks
Secondary outcomes (1)
Oxygen saturation
Pulse oximeter will be used on participant to measure Spo2.
Measured: after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Sep 2023
- Primary completion1 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suman Sheraz, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876637
- Sponsor's protocol ID
- Muqaddas Bibi
- Status last verified
- Jan 2024
- First submitted
- 17 May 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shah N, Shah Q, Shah AJ. The burden and high prevalence of hypertension in Pakistani adolescents: a meta-analysis of the published studies. Arch Public Health. 2018 Apr 2;76:20. doi: 10.1186/s13690-018-0265-5. eCollection 2018.
PubMed 29619218Malhotra V, Srivastava R, Parasuraman P, Javed D, Wakode S, Thakare A, Sampath A, Kumari A. Immediate autonomic changes during right nostril breathing and left nostril breathing in regular yoga practitioners. J Educ Health Promot. 2022 Aug 25;11:280. doi: 10.4103/jehp.jehp_343_22. eCollection 2022.
PubMed 36325230Jain N, Srivastava RD, Singhal A. The effects of right and left nostril breathing on cardiorespiratory and autonomic parameters. Indian J Physiol Pharmacol. 2005 Oct-Dec;49(4):469-74.
PubMed 16579402Bargal S, Nalgirkar V, Patil A, Langade D. Evaluation of the Effect of Left Nostril Breathing on Cardiorespiratory Parameters and Reaction Time in Young Healthy Individuals. Cureus. 2022 Feb 18;14(2):e22351. doi: 10.7759/cureus.22351. eCollection 2022 Feb.
PubMed 35371755Wood DL, Sheps SG, Elveback LR, Schirger A. Cold pressor test as a predictor of hypertension. Hypertension. 1984 May-Jun;6(3):301-6. doi: 10.1161/01.hyp.6.3.301.
PubMed 6735451
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Left Nostril Breathing in Young Females Having Cardiovascular Hyper Reactivity to Cold Pressor Test.
- ClinicalTrials.gov ID
- NCT05876637
- Acronym / sponsor ID
- Muqaddas Bibi
- Conditions
- Healthy
- Keywords
- blood pressure, cold pressor test, heart rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 25 May 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.
The purpose of this study is to evaluate the effects of left nostril breathing in young females having cardiovascular hyper reactivity to cold pressor test.Although,limited literature exist regarding hyper reactivity towards stress induced test in our youth and its effective and easy treatment in the form of left nostril breathing which could proves to be beneficial for our youth.
Detailed description
The Cold Pressor Test (CPT) was introduced as a standard incentive for studying the vasomotor response (Hines and Brown 1932). Hyper-reactors were the subjects in his study who responded more strongly to CPT, Participants who show hyper reactivity to Cold pressor test (i.e. subjects showing 25 mmHg increase in systolic blood pressure along with 20 mmHg increase in diastolic blood pressure).They proposed that these hyper reactive could be candidates for hypertension in the future. Increased occurrence of these diseases could be attributed to an asymmetry in sympathetic and parasympathetic stimulation. Control or adaptation of breathing or breathing workouts i-e yoga are thought to be beneficial in the treatment of such disease. Although Yoga techniques proven to be effective in treating stress related disorders but it is time consuming and young population because of their busy routine couldn't be able to take out time for their health related issues. This study introduces very simple exercise in the form of left nostril breathing which decreases sympathetic activity and increases parasympathetic activity. It is inversely proportional to stress induced response of the body, it is very easy to perform and can be done at any time, and if found significantly effective for stress disorder ,it could be used in daily routine by our youth to get themselves prevented from major risk factors of CVD's particularly hypertension. This study will identify participants with a high potential risk of developing hypertension in the future by administering Cold pressor test, additionally the effects of left nostril breathing intervention on hyper reactive participants would be observed and if found significant, it would be a major breakthrough in primary prevention of hypertension.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left Nostril Breathing | Experimental | Other: Left Nostril BreathingThe intervention protocol include healthy young females age 18-25 years.. All baseline measurements will be taken , Afterwards, the Cold pressor test would be performed for 1 minutes to induce acute stress while the BP would be monitored for every 30 seconds. At the end of the test, again the BP would be monitored. Out of all the recordings, the BP measuring the highest value would be recorded as final. We will then subtract the normal resting BP by highest value of the recording for each participant. Change in BP of systolic by 25mmHg and diastolic by 20mmHg will be considered hyper reactive. Then the hyper reactive subjects will be divided into two groups. Experimental group will receive left nostril breathing. CPT will be performed again at 4, 8 and 12 weeks to monitor the BP, heart rate and Spo2 likewise to check for any decline in sympathetic activity. |
| Conventional | Active comparator | Other: ConventionalThe conventional protocol include healthy young females age 18-25 years. All baseline measurements will be taken, Afterwards, the Cold pressor test would be performed for 1 minutes to induce acute stress while the BP would be monitored for every 30 seconds. At the end of the test, again the BP would be monitored. Out of all the recordings, the BP measuring the highest value would be recorded as final. We will then subtract the normal resting BP by highest value of the recording for each participant. Change in BP of systolic by 25mmHg and diastolic by 20mmHg will be considered hyper reactive. Then the hyper reactive subjects will be divided into two groups Group A(Experimental) and Group B(Conventional). Controlled group will receive simple deep breathing exercises ,3 sessions per week for 12 weeks. CPT will be performed again at 4, 8 and 12 weeks to monitor the BP, heart rate and Spo2 likewise to check for any decline in sympathetic activity. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants falling in the following category would be recruited into the study:
- Females Age (18-25) years
- Participants who show hyper reactivity to Cold pressor test (i.e subjects showing 25mmHg increase in systolic blood pressure along with 20mmHg increase in diastolic blood pressure)
- Consenting participants.
Key exclusion criteria (6 listed)
- The participants in the following category would be excluded from the study:
- Participants on antihypertensive drugs.
- Participants who are diagnosed with any cardiovascular, renal, hepatic or metabolic disease.
- Participants having malignant tumor.
- Participants with nasal blockages, polyps ,Raynaud phenomena
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 |
|---|---|---|
| Left Nostril BreathingThe participants which will show cardiovascular hyper reactivity towards CPT will be divided into 2 groups having 30 participants in each group. Experimental group will receive Left Nostril Breathing(slow, deep breath taken through your left nostril while closing your right nostril with your right thumb. Then just as gently exhale long, slowly, and completely through the left nostril, just as gently. It will be done while sitting) for 10 minutes twice a day for the duration of 12 weeks. Follow up will be taken through administration Cold pressor test after every 4,8 and 12 weeks. | Other | Left Nostril Breathing |
| Conventional30 participants will be recruited in conventional group which will receive simple deep breathing exercises of 3 sessions per week for the duration of 12 weeks.Follow up will be taken after every 4,8 and 12 weeks. | Other | Conventional |
Primary outcome
Cold pressor test
Time frame: After 4 weeks
Cold pressor test will be conducted on participants to measure cardio vascular hyper reactivity to stress induce test.
Blood pressure
Time frame: After 4 weeks
Mercury sphygmomanometer will be used to measure blood pressure of participants
Heart Rate
Time frame: After 4 weeks
Pulse oximeter will be applied to the participant to measure their Heart rate.
1 secondary outcome
Oxygen saturation
Time frame: after 4 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 30 Jan 2024.
- Background: PubMed 29619218Shah N, Shah Q, Shah AJ. The burden and high prevalence of hypertension in Pakistani adolescents: a meta-analysis of the published studies. Arch Public Health. 2018 Apr 2;76:20. doi: 10.1186/s13690-018-0265-5. eCollection 2018.
- Background: PubMed 36325230Malhotra V, Srivastava R, Parasuraman P, Javed D, Wakode S, Thakare A, Sampath A, Kumari A. Immediate autonomic changes during right nostril breathing and left nostril breathing in regular yoga practitioners. J Educ Health Promot. 2022 Aug 25;11:280. doi: 10.4103/jehp.jehp_343_22. eCollection 2022.
- Background: PubMed 16579402Jain N, Srivastava RD, Singhal A. The effects of right and left nostril breathing on cardiorespiratory and autonomic parameters. Indian J Physiol Pharmacol. 2005 Oct-Dec;49(4):469-74.
- Background: PubMed 35371755Bargal S, Nalgirkar V, Patil A, Langade D. Evaluation of the Effect of Left Nostril Breathing on Cardiorespiratory Parameters and Reaction Time in Young Healthy Individuals. Cureus. 2022 Feb 18;14(2):e22351. doi: 10.7759/cureus.22351. eCollection 2022 Feb.
- Background: PubMed 6735451Wood DL, Sheps SG, Elveback LR, Schirger A. Cold pressor test as a predictor of hypertension. Hypertension. 1984 May-Jun;6(3):301-6. doi: 10.1161/01.hyp.6.3.301.
- 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.
Suman Sheraz, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left Nostril Breathing and Conventional in people with Healthy, run by Riphah International University at 1 site in Pakistan.
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 6 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 30 Jan 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 Pakistan. 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?
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?
Cold pressor test (time frame: After 4 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?
On the ClinicalTrials.gov record for NCT05876637, which also lists 5 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 30 Jan 2024.