Bumblebee Breath Effect on Tinnitus in Older Patients

NCT05198973 | Unknown

• 1 other identifier: P.T.REC/012/003456
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus, Subjective

Outcome Measures

Primary Outcomes (1)

• Tinnitus Handicap Inventory

  life-quality inquiry in tinnitus subjects (if its score decreases, it means tinnitus improvement)

  week 4

Secondary Outcomes (6)

• visual analogue scale for tinnitus annoyance

  week 4

• visual analogue scale for tinnitus loudness

  week 4

• pulse rate

  week 4

• respiratory rate

  week 4

• systolic blood pressure

  week 4

Study Arms (2)

Bumblebee Breath group

EXPERIMENTAL

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

control group

NO INTERVENTION

this group (28 patients) will receive no training

Interventions

Bumblebee Breath 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)

Bumblebee Breath group

Eligibility Criteria

• Age: 65 Years - 75 Years
• Gender Eligibility Details: self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• elderly males and females
• Tinnitus complaints

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Unoversity

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ali Ismail, lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, lecturer

CONTACT

02 01005154209; allooka2012@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: January 20, 2022
• Study Start: November 8, 2021
• Primary Completion: February 28, 2022
• Study Completion: March 1, 2022
• Last Updated: January 20, 2022

Record last verified: 2022-01

Locations

EG (1)