Bumblebee Breath Effect on Tinnitus in Older Patients

Tinnitus, Subjective Clinical Trial

Official title:

Bumblebee Breath Effect on Tinnitus in Older Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05198973
• Other study ID #: P.T.REC/012/003456
• Status: Recruiting
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

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