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Bumblebee Breath Effect on Tinnitus in Older Patients

Primary Purpose

Tinnitus, Subjective

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bumblebee Breath
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tinnitus, Subjective

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • elderly males and females
  • Tinnitus complaints

Exclusion Criteria:

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

Sites / Locations

  • Cairo UnoversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bumblebee Breath group

control group

Arm Description

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)

this group (28 patients) will receive no training

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

visual analogue scale for tinnitus annoyance
measures of tinnitus annoyance
visual analogue scale for tinnitus loudness
measures of tinnitus loudness
pulse rate
autonomic-status assessment
respiratory rate
autonomic-status assessment
systolic blood pressure
force of blood during ventricular contraction
diastolic blood pressure
force of blood during ventricular relaxation

Full Information

First Posted
December 5, 2021
Last Updated
January 5, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05198973
Brief Title
Bumblebee Breath Effect on Tinnitus in Older Patients
Official Title
Bumblebee Breath Effect on Tinnitus in Older Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bumblebee Breath group
Arm Type
Experimental
Arm Description
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)
Arm Title
control group
Arm Type
No Intervention
Arm Description
this group (28 patients) will receive no training
Intervention Type
Behavioral
Intervention Name(s)
Bumblebee Breath
Intervention Description
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)
Primary Outcome Measure Information:
Title
Tinnitus Handicap Inventory
Description
life-quality inquiry in tinnitus subjects (if its score decreases, it means tinnitus improvement)
Time Frame
week 4
Secondary Outcome Measure Information:
Title
visual analogue scale for tinnitus annoyance
Description
measures of tinnitus annoyance
Time Frame
week 4
Title
visual analogue scale for tinnitus loudness
Description
measures of tinnitus loudness
Time Frame
week 4
Title
pulse rate
Description
autonomic-status assessment
Time Frame
week 4
Title
respiratory rate
Description
autonomic-status assessment
Time Frame
week 4
Title
systolic blood pressure
Description
force of blood during ventricular contraction
Time Frame
week 4
Title
diastolic blood pressure
Description
force of blood during ventricular relaxation
Time Frame
week 4

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
self-representation of gender identity.
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: elderly males and females Tinnitus complaints Exclusion Criteria: cardio(respiratory) symptoms, any local (within ear) problem(s).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo Unoversity
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
01005154209
Email
allooka2012@gmail.com

12. IPD Sharing Statement

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Bumblebee Breath Effect on Tinnitus in Older Patients

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