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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05198973
Other study ID # P.T.REC/012/003456
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 8, 2021
Est. completion date March 1, 2022

Study information

Verified date January 2022
Source Cairo University
Contact Ali Ismail, lecturer
Phone 02 01005154209
Email allooka2012@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Tinnitus is a condition in which the person hears sound, which isn't coming from the external environment, often, described as ringing in the ears. Patients describe the condition as an annoyance and disturbance and in turn this correlates with increased levels of anxiety and depression. Currently, there is no single effective treatment for tinnitus so research continues to look for new ways to treat and manage the condition. Bumblebee Breath starts by finding a relaxed, supported posture, either laying supine or in seated and then bringing the minds attention to the space between the eyebrows (or third eye in yoga terms). With the eyes close the thumbs are placed over the tragus of the ears, the first finger gently rests on eye lids, middle finger touches the sides of the nose and then the index and pinkie rest just above and below the closed lips. Next, a sound is created by inhaling deeply through the nose and exhaling with a low-pitched humming sound. The result sounds very much like a bee buzzing to the person performing the breath and a sensation of vibration is experienced inside the head and over the face. this study is designed to assess Bumblebee Breath on tinnitus.


Description:

two groups (28 for each) will included. One tinnitus group will receive half an hour of Bumblebee Breath training (daily) for one month. The second one will receive nothing


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date March 1, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years to 75 Years
Eligibility Inclusion Criteria: - elderly males and females - Tinnitus complaints Exclusion Criteria: - cardio(respiratory) symptoms, any local (within ear) problem(s).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Bumblebee Breath
Bumblebee Breath starts by finding a relaxed, supported posture, either laying supine or in seated and then bringing the minds attention to the space between the eyebrows (or third eye in yoga terms). With the eyes close the thumbs are placed over the tragus of the ears, the first finger gently rests on eye lids, middle finger touches the sides of the nose and then the index and pinkie rest just above and below the closed lips. Next, a sound is created by inhaling deeply through the nose and exhaling with a low-pitched humming sound. The result sounds very much like a bee buzzing to the person performing the breath and a sensation of vibration is experienced inside the head and over the face. this will applied half an hour daily for ( 1 month)

Locations

Country Name City State
Egypt Cairo Unoversity Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tinnitus Handicap Inventory life-quality inquiry in tinnitus subjects (if its score decreases, it means tinnitus improvement) week 4
Secondary visual analogue scale for tinnitus annoyance measures of tinnitus annoyance week 4
Secondary visual analogue scale for tinnitus loudness measures of tinnitus loudness week 4
Secondary pulse rate autonomic-status assessment week 4
Secondary respiratory rate autonomic-status assessment week 4
Secondary systolic blood pressure force of blood during ventricular contraction week 4
Secondary diastolic blood pressure force of blood during ventricular relaxation week 4
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