Executive
Summary for Original Acoustic Research Projects: October 18, 2004
John S Viviano, BSc, DDS,
obtained
his degrees from the University of Toronto and has maintained a private
practice of General, Family and Cosmetic Dentistry in Ontario, Canada since
1983.
He is
credentialed by the certifying board of the Academy of Dental Sleep Medicine
and maintains a special interest in the conservative treatment of
sleep-disordered breathing. Dr. Viviano lectures internationally on the
treatment of sleep disordered breathing and the use of Airway Acoustics. He
has authored articles reviewing Airway Acoustics and establishing protocols
for its use in assessing airway normalization.
Giora Pillar, MD, PhD.,
is a sleep researcher and physician in the sleep lab at Rambam Medical
Center, and senior lecturer at the Faculty of Medicine, Technion-Israel
Institute of Technology, Haifa, Israel. He obtained his medical and
scientific degree from the Technion, and thereafter completed a fellowship
at the Sleep Medicine, Endocrinology and Circadian Rhythm Department,
Brigham & Women Hospital and Harvard Medical School, Boston, USA. He has the
American Board of Sleep Medicine examinations certification, and has 15-year
experience in diagnosing and treating patients with sleep disorders.
Dr.
Pillar’s many research projects include the study of structure and function
of the apneic airway, state dependant characteristics, and gender
influence. He lectures internationally on sleep medicine and is the author
of a book entitled “Sleep Disorders: Diagnosis, Management, and Treatment. A
Handbook for Clinicians”. Dr. Pillar is the recipient of several awards for
his work in the field of sleep.
Project One:
40 Obese Male Apneics
(BMI>30)
(n=20 Acoustic Group, n=20 Control Group)
Project Two:
40 Non-Obese Male Apneics
(BMI<30)
(n=20 Acoustic Group, n=20 Control Group)
Purpose: To evaluate the Utility of Airway Acoustic
Evaluation of Airway Dynamics in Apneic Males
Priori Hypothesis:
Acoustic evaluation of awake airway dynamics has utility in establishing airway
orthotic candidacy, construction, titration & maintenance parameters.
Group A : Orthotic titrated by patient “subjective
feedback questionnaire” and optimum airway normalization as determined by airway
acoustics
Group B: (Control) Orthotic titrated by patient
“subjective feedback questionnaire” (Usual and Customary Protocol)
Inclusion Criteria:
Males 40<age<60, Newly diagnosed apnea, or failed, refused or
never tried CPAP with polysomnogram verified 15<RDI<90.
Exclusion Criteria:
Use of alpha
blockers, steroids or medications affecting upper airway tone (benzodiazepines,
sedatives etc.), unstable medical condition, regular CPAP use within the
previous 6 months, clinical evidence for hypothyroidism, TMD, lack of healthy
dentition, Restricted Range of Mandibular Motion. Significant weight increase
since Baseline Sleep Study.
General:
Groups matched for BMI, RDI, age, and ethnic background.
Participants receive consultation, acoustic evaluations, WP100 evaluations,
airway orthotic and airway orthotic therapy at no fee; value $1,500 - $2,000 CA.
In-lab Polysomnograms and physician time covered by OHIP. Patients, Physician
and Sleep Technicians will be Blind to which group the patient is in.
|
Stage |
Group A (Acoustic Group)
Acoustic Orthotic Protocol n=20 |
Group B (Control Group)
Usual & Customary Orthotic Protocol n=20 |
|
Stage I
|
Initial Screening:
·
Clinical Oral Examination and Medical History
·
Confirm Candidacy as per Inclusion/Exclusion Criteria
·
Symptom Questionnaire (used to establish end-point)
·
Consent for Therapy and Study Participation
·
Baseline Acoustic Evaluation (Pharyngeal and Nasal)
·
Pharyngeal Acoustic Evaluation at Various Mandibular
Postures
·
Baseline WP100 Diagnosis
·
Go to Stage II-a ASAP |
Initial Screening:
·
Clinical Oral Examination and Medical History
·
Confirm Candidacy as per Inclusion/Exclusion Criteria
·
Symptom Questionnaire (used to establish end-point)
·
Consent for Therapy and Study Participation
·
Baseline Acoustic Evaluation (Pharyngeal and Nasal)
·
Pharyngeal Acoustic Evaluation at Various Mandibular
Postures
·
Baseline WP100 Diagnosis
·
Go to Stage II-a ASAP |
|
Stage II-a
|
Alginate Impressions & Record taking for Orthotic
Go
to Stage II-b in one week |
Alginate Impressions & Record taking for Orthotic
Go
to Stage II-b in one week |
|
Stage II-b
|
Insert Orthotic: Evaluate vertical using acoustics to establish optimum
airway response
*use
Optimum vertical with first advancement position
Go
to Stage II-c in two weeks |
Insert Orthotic: Evaluate vertical using acoustics to establish optimum
airway response
*use
Minimum vertical with first advancement position
Go
to Stage II-c in two weeks |
|
Stage II-c
|
Symptom questionnaire.
Advance orthotic, evaluate vertical using acoustics to establish optimum
airway response
*use
Optimum vertical then go to Stage II-d.
If
patient cannot accommodate further advancement then go to
Stage III ASAP |
Symptom questionnaire.
Advance orthotic, evaluate vertical using acoustics to establish optimum
airway response
*use
Minimum vertical then go to Stage II-d.
If
patient cannot accommodate further advancement then go to Stage III
ASAP |
|
Stage II-d |
Repeat Stage II-c after 2 weeks of continuous nightly wear |
Repeat Stage II-c after 2 weeks of continuous nightly wear |
|
Stage III-a
|
Set
Orthotic at setting that provides optimum questionnaire results and
optimum airway normalization established through acoustics.
Pharyngeal acoustic evaluation with orthotic in place, WP100 evaluation,
arrange in-lab polysomnogram |
Set
orthotic at setting that provides optimum questionnaire results with
minimum advancement.
Pharyngeal acoustic evaluation with orthotic in place, WP100 evaluation,
arrange in-lab polysomnogram |
|
Stage III-b
|
Failed orthotic outcome:
titration protocol switched to that of group B & Acoustics, WP100,
Questionnaire & in-lab Sleep Study are repeated. |
Failed orthotic outcome:
titration protocol switched to that of group A & Acoustics, WP100,
Questionnaire & in-lab Sleep Study are repeated. |
|
Stage IV
|
3
month and yearly follow-up appointments to document, subjective
satisfaction by questionnaire, orthotic compliance, and utility of
acoustics and WP100 to establish efficacy. In-lab polysomnogram on a
yearly basis |
3
month and yearly follow-up appointments to document, subjective
satisfaction by questionnaire, orthotic compliance, and utility of
acoustics and WP100 to establish efficacy. In-lab polysomnogram on a
yearly basis |
