Bumblebee Breath Effect on Tinnitus in Older Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Tinnitus, Subjective
• Intervention / Treatment: Behavioral: Bumblebee Breath

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

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Cairo Unoversity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 75 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• elderly males and females
• Tinnitus complaints

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	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)
No Intervention: control group; this group (28 patients) will receive no training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinnitus Handicap Inventory	life-quality inquiry in tinnitus subjects (if its score decreases, it means tinnitus improvement)	week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue scale for tinnitus annoyance	measures of tinnitus annoyance	week 4
visual analogue scale for tinnitus loudness	measures of tinnitus loudness	week 4
pulse rate	autonomic-status assessment	week 4
respiratory rate	autonomic-status assessment	week 4
systolic blood pressure	force of blood during ventricular contraction	week 4
diastolic blood pressure	force of blood during ventricular relaxation	week 4

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: December 5, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: P.T.REC/012/003456

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No