Bumblebee Breath Effect on Tinnitus in Older Patients

NCT ID: NCT05198973

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-08
• Study Completion Date: 2022-03-01

Brief 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.

Detailed 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

Conditions

Tinnitus, Subjective

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Bumblebee Breath group

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 group will be 28 patients to receive half an hour daily for ( 1 month)

Group Type: EXPERIMENTAL

Bumblebee Breath

Intervention Type: BEHAVIORAL

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)

control group

this group (28 patients) will receive no training

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• elderly males and females
• Tinnitus complaints

Exclusion Criteria

• cardio(respiratory) symptoms, any local (within ear) problem(s).

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ali Mohamed Ali ismail

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Ismail, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo Unoversity

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ali Ismail, lecturer

Role: CONTACT

allooka2012@gmail.com

02 01005154209

Facility Contacts

Ali Ismail, lecturer

Role: primary

allooka2012@gmail.com

01005154209

Other Identifiers

P.T.REC/012/003456

Identifier Type: -

Identifier Source: org_study_id