1

SYNOPSIS

OF

DISSERTATION

Dr.LOHITH B R

DEPT OF OTORHINOLARYNGOLOGY

COMMAND HOSPITAL (AIR FORCE)

BANGALORE-07

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

SYNOPSIS FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / Name of the Candidate and address (in block letters) / DR LOHITH B R
DEPT OF OTORHINOLARYNGOLOGY,
COMMAND HOSPITAL,
AIR FORCE,
BANGALORE – 560 007.
2. / Name of the institution / COMMAND HOSPITAL,
AIR FORCE,
BANGALORE – 560 007.
3. / Course of study and subject / MS ENT
4. / Date of admission of course / 01 JULY 2013
5. / Title of the topic /

A STUDY OF THE MORPHOLOGY OFUPPER AERODIGESTIVE TRACT IN SUBJECTS WITH SNORING AND OBSTRUCTIVE SLEEP APNEA SYNDROME.

6.Brief resume of the intended work:

A6.1 NEED FOR STUDY

In the recent years, snoring and obstructive sleep apnea syndrome has emerged as an important public health problem.Snoringis the vibration of respiratory structures and the resulting sound, due to obstructed air movement duringbreathingwhilesleeping. Snoring is known to causesleep deprivationto snorers and those around them, as well as daytimedrowsiness,irritability, lack ofconcentration.It has also been suggested that it can cause significant psychological and social damage to sufferers.

The mechanism of snoring and obstructive sleep apnea syndrome has been related to increased upper airway collapsibility and reduction of upper airway size, alterations in craniofacial structure and enlargement of surrounding soft tissue structures (i.e., tongue and lateral pharyngeal walls).The upper airway evaluation has indubitably contributed to understand the pathophysiology and the diagnosis of sleep related breathing disorders and snoring. Additionally, it also helps to identify the subjects with increased risk as well as to select the more appropriate modality of treatment, especially for surgical procedures.The upper airway is both anatomically and functionally complexand contains multiple vital structures in close proximity.

In this study we are studying the morphology of upper aerodigestive tract in subjects with snoring and obstructive sleep apnea syndrome, evaluated byflexible fibreoptic nasolaryngoscopy and magnetic resonance imagingwhich provides us with valuable data about the anatomical risk factors contributing to snoring and obstructive sleep apnea syndrome.

B 6.2 REVIEW OF LITERATURE

1.Sonia Maria1 et al conducted a study to evaluate the upper airway which included the physical examination of pharyngeal structures and a number of imaging techniques that vary from the commonlyused lateral cephalometry to tri-dimensional MRI. The study concluded stating that this evaluation has contributed to understandthe pathophysiology and the diagnosis of obstructive sleep apnea syndrome and snoring. In general, in clinical practice only simple imaging techniques have been utilised, however, the imaging techniques of high complexity provide further information about anatomy and function of upper airway, leading to more appropriate management of this prevalent respiratory sleep disorder.

2.Danoy MC2, et al showed that the pharyngeal video fibroscopy should complete the classical diagnostical management of eachsnoringassociated with obstructive sleep apnea. Easily made on a seatedawakepatient the pharyngeal video fibroscopy is the one dynamical pharyngeal procedure. The Müller test seats the level of this obstruction, helps the surgeon in the choice of the procedure and should reduce the failure rate.

3.Identification of Upper Airway Anatomic Risk Factors for Obstructive Sleep Apnea with Volumetric Magnetic Resonance Imaging was done by Richard J Schwab3 et al. They used volumetric MRI to identify structural risk factors for obstructive sleep apnea. MR imaging and computerbased analysis techniques allowed to objectively quantify the volume of the tongue, soft palate, parapharyngeal fat pads, and lateral pharyngeal walls. Increased tongue, total soft tissue and lateral pharyngeal wall volumes are all important risk factors for sleep apnea. After adjusting for ethnicity, sex, age, craniofacial size and visceral fat in the neck there was a significantly increased risk of developing sleep apnea, the larger the volume of the tongue, lateral pharyngeal walls, and total soft tissue.

4.To characterise the relation betweenpharyngealanatomy andsleeprelated disordered breathing, the study done by Rodenstein DO4 et al which includes 17 men with complaints of snoring. Ten of them hadobstructivesleepapnoeawhereas seven were simplesnorers. The pharynx was studied by magnetic resonance imaging in allpatientsand in a group of eighthealthysubjects. On the midsagittal section and six transverse sections equally spaced between the nasopharynx and the hypopharynx several anatomical measurements were performed. Results showed that there was no difference between groups in most magnetic resonance imaging measurements, but that on transverse sections thepharyngealcross section had an ellipticshapewith the long axis oriented in the coronal plane in normalsubjects, whereas in apnoeic and snoringpatientsthe pharynx was circular or had an ellipticshapebut with the long axis oriented in the sagittal plane. It is suggested that the change inpharyngealcross sectionalshape, secondary to a reduction inpharyngealtransverse diameter, may be related to the risk of developingsleeprelated disordered breathing.

C 6.3 OBJECTIVES OF THE STUDY

The purpose of this study is to evaluate the morphology of upper aerodigestive tract in subjects with snoring and obstructive sleep apnea syndrome.

7. MATERIALS AND METHOD

This study examines 30 patients with complaints of snoring and diagnosed obstructive sleep apnea syndromepresenting to the ENT OPD and they will be evaluated withdetailed history, complete nose and throat examination with flexible fibreoptic nasolaryngoscopy to visualize and document the anatomical structures in awake state with Mullersmanoeuvreand Magnetic resonance imaging for airway assessment.

A 7.1 SOURCE OF DATA:

A study will be conducted at Command Hospital, Air Force Bangalore in the Department of Otorhinolaryngology.The study will include 30 patients, withsnoring and obstructive sleep apnea syndrome.

B 7.2 METHOD OF COLLECTION OF DATA:

Clinical data are collected from the patients above the age of 16 years, presenting with snoring and obstructive sleep apnea syndromeafter taking informed consent to participate in the study.

EXCLUSION CRITERIA :

  1. History of any congenital structural anomalies.
  2. Patients who have undergone previous nasal and oropharyngeal surgery.
  3. Patients with diagnosed upper aerodigestive malignancies.
  4. Patients who are pregnant.
  5. Patients with chronic intake of sedative medications.
  6. Patients with a metallic object in the body or other contraindication to MRI.

C 7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION TO BE CONDUCTED ON PATIENT OR OTHER HUMANS OR ANIMALS?

All subjects will undergo flexible fibreopticnasolaryngoscopy under Local anesthesia (4% Lignocainespray)in ENTOPD and Magnetic resonance imaging for airway assessment.

D 7.4 METHOD OF ANALYSIS :

The Patientswith snoring and obstructive sleep apnea syndromewill be evaluated by clinical examination, endoscopic examination, and radiological imaging to assess the anatomical morphology of the upper aerodigestive tract.Patient records will be documented and the data compiled for analysis.These are analysed with standard method of analysis.

Conclusion will be drawn based on the observations made during the study period.

Has the ethical clearance been obtained fom your institution. Yes.

8. REFERENCES:

  1. Sonia Maria G.P et al; Evaluation of the upper airway in obstructive sleep apnoea. Indian J Med Res 131, 2010, pp 230-235.
  1. Danoy MC,etal; Pharyngeal video-fibroscopy: value in the management of apneicsnoring]. Rev LaryngolOtolRhinol (Bord).1992;113(4):369-73
  1. Richard J. Schwab et al; Am J RespirCrit Care Med Vol 168. pp 522–530, 2003.
  1. Rodenstein DO et al; Pharyngeal shape and dimensions inhealthy subjects, snorers, and patients with obstructive sleepapnoea. Thorax 1990; 45 : 722-7.
  1. Shepard JW et al; Evaluationof the upper airway in patients with obstructive sleep apnea.Sleep1991; 14 : 361-71.
  1. Georgalas C et al; Assessmentof obstruction level and selection of patients for obstructivesleepapnoea surgery:J LaryngolOtol2010; 124 : 1-9
  1. Robertson S, The role of ENT surgeons in snoring assessment. ClinOtolaryngol. 2008 Oct;33(5):458-61.
  1. Kimoff RJ, Sforza E, Champagne V, Ofiara L, Gendron D. Upper airwaysensation in snoring and obstructive sleep apnea. Am J RespirCritCare Med 2001;164:250–255.

9. / Signature of Candidate
10. / Remarks of Guide / A STUDY OF THE MORPHOLOGY OF UPPER AERODIGESTIVE TRACT IN SUBJECTS WITH SNORING AND OBSTRUCTIVE SLEEP APNEA SYNDROME. is feasible as a dissertation topic. Clinical materials will be available in this hospital for the study.
11. / Name and Designation of (in block letters)
11.1 Guide
11.2 Signature
11.3 Co-Guide
11.4 Signature
11.5 Co-Guide
11.6 Signature
11.7 Head of Dept
11.8 Signature / COL SABARIGIRISH K
PROFESSOR AND HEAD OF DEPARTMENT,
OTORHINOLAYNGOLOGY,
COMMAND HOSPITAL (AIRFORCE), BANGALORE- 07
GP CAPT SANJEEV SAXENA
ASSOCIATE PROFESSOR ,
DEPARTMENT OF
OTORHINOLAYNGOLOGY,
COMMAND HOSPITAL (AIRFORCE), BANGALORE- 07
WG CDR SK A RAHEEM,
ASSISTANT PROFESSOR,
DEPT OF RADIODIAGNOSIS,
COMMAND HOSPITAL (AIRFORCE), BANGALORE- 07
COL SABARIGIRISH K
PROFESSOR AND HEAD OF THE DEPT,
OTORHINOLARYNGOLOGY,
COMMAND HOSPITAL,
AIRFORCE, BANGALORE-07.
12.1 Remarks of the chairman and principal
12.2 Signature / AVM RAJVIR BHALWAR,
COMMANDANT AND PRINCIPAL,
COMMAND HOSPITAL,
AIR FORCE, BANGALORE-07

CERTIFICATE FROM ETHICAL COMMITTEE

  1. The Committee has examined the scope including the need, objectives, method of data collection and human interventions of the following study to be carried out by Dr Lohith B R, MS student (Department of Otorhinolaryngology) under the guidance of Col Sabarigirish K and the title of which is:

ASTUDY OF THE MORPHOLOGY OF UPPER AERODIGESTIVE TRACT IN SUBJECTS WITH SNORING AND OBSTRUCTIVE SLEEP APNEA SYNDROME.

  1. The committee has no objection for undertaking this study at Command Hospital (Air Force), Bangalore.

(SaliniChaudhary) (S Kaistha) (SK Jha) (SC Dash) (MS Prakash) (H Sahni)

Sq Leader Wg Cdr Col Col Brig Gp Capt

OIC Legal Cell Rep of AFWWA OIC Prof & HOD Prof & HOD OIC AFMRC Member Member PG Cell Surgery Medicine Member

Member Member Member Secretary

(Mrs. VasanthaKishore) (Dr V Sinha)

Counsellor Scientist ‘D’ Physiologist

E- support Member

Member

(MK Bedi)

Air Cmde

AOC MTC

Chairman Ethical Committee

Command Hospital (Air Force)

Bangalore – 560007

CERTIFICATE OF ACCEPTANCE BY THE GUIDE

I, Col SabarigirishK , Professor and Head of Department of Otorhinolaryngology, Command Hospital (Air Force), Bangalore, hereby certify that I accept Dr Lohith B R as a candidate for MS ENTcourse. The title of hisdissertation is as follows-

ASTUDY OF THE MORPHOLOGY OF UPPER AERODIGESTIVE TRACT IN SUBJECTS WITH SNORING AND OBSTRUCTIVE SLEEP APNEA SYNDROME.

He will beunder my guidance during the entire period of his study and thesis work.

Date:

Place: Bangalore

(Sabarigirish K)

Col

Professor & HOD

Dept of Otorhinolaryngology

Command Hospital Air Force,

Bangalore-07

CERTIFICATE OF ACCEPTANCE BY THE CO-GUIDE

I, Wg Cdr SK A Raheem,Assistant professor,Dept of Radiodiagnosis, Command Hospital (Air Force), Bangalore, hereby certify that I accept Dr Lohith B R as a candidate for MS ENT course. The title of his dissertation is as follows-

ASTUDY OF THE MORPHOLOGY OF UPPER AERODIGESTIVE TRACT IN SUBJECTS WITH SNORING AND OBSTRUCTIVE SLEEP APNEA SYNDROME.

He will beunder my guidance during the entire period of his study and thesis work.

Date:

Place: Bangalore

(SK A Raheem)

Wg Cdr

Assistant Professor

Dept of Radiodiagnosis

Command Hospital Air Force,

Bangalore-07

CERTIFICATE OF ACCEPTANCE BY THE CO-GUIDE

I, Gp Capt SanjeevSaxena, Associate Professor,Department of Otorhinolaryngology, Command Hospital (Air Force), Bangalore, hereby certify that I accept Dr Lohith B R as a candidate for MS ENT course. The title of his dissertation is as follows-

ASTUDY OF THE MORPHOLOGY OF UPPER AERODIGESTIVE TRACT IN SUBJECTS WITH SNORING AND OBSTRUCTIVE SLEEP APNEA SYNDROME.

He will beunder my guidance during the entire period of his study and thesis work.

Date:

Place: Bangalore

(SanjeevSaxena)

Gp Capt

Associate Professor

Dept of Otorhinolaryngology

Command Hospital Air Force,

Bangalore-07

CERTIFICATE FROM THE HEAD OF THE INSTITUTION

Permission is hereby accorded to the student Dr.Lohith B R, to undergo MS ENT course being conducted at Command Hospital Air Force, Bangalore affiliated to Rajiv Gandhi University of Health Sciences Karnataka, Bangalore commencing from July 2013 under the guidance of Col Sabarigirish K, Professor and Head of the Dept of Otorhinolaryngology, Command Hospital Air Force, Bangalore- 560007.

Date :

Place :Bangalore

AVM RAJVIR BHALWAR

Commandant and Principal, Command Hospital (Air Force), Bangalore- 560007.

STUDY INFORMATION SHEET FOR PATIENTS

Title: A STUDY OF THE MORPHOLOGY OF UPPER AERODIGESTIVE TRACT IN SUBJECTS WITH SNORING AND OBSTRUCTIVE SLEEP APNEA SYNDROME.

Student – Dr Lohith B R

Guide – Col Sabarigirish K

Purpose of study:

.The purpose of this study is to evaluate the morphology of upper aerodigestive tract in subjects with snoring and obstructive sleep apnea syndrome

Procedure

(a)A study will be conducted at Command Hospital, Air Force Bangalore in the Department of Otorhinolaryngology.

(b)The patients above the age of 16 years, presenting with snoring and obstructive sleep apnea syndromeafter taking informed consent to participate in the study.

(c)All subjects will undergo flexible fibreopticnasolaryngoscopy under Local anesthesia (4% lignocaine spray) in ENT OPD and Magnetic resonance imaging for airway assessment

(d)Informed consent will be taken from patients and clinical details will be collected from the pateints.

Contraindications, do’s and do not’s

a)You cannot be taken up for MRI examination if you have any of the following medical implants, devices in your body: Cardiac Pacemaker, aneurysmal clips, artificial heart valves, aortic clips, and any other ferromagnetic objects.

c)Do not enter the MRI scanning room with hearing aids, wallet, jewellery, watch, coins, mobile, keys, hairpins, safety pins, pens, magnetic strip cards (credit and debit cards)

Confidentiality and incidental detection of abnormalities

All information that patients provide during the study will be used for study purpose only and will not be communicated to others. In case of detection of any incidental abnormality on MRI, they will be communicated the same and relevant referral will be done.

Contacts

If you have any further questions or any time during the course of the study you feel that you need additional information about any procedure, you can contact the following:

Dr Lohith B R

Resident

Dept of Otorhinolaryngology

Command Hospital Air force

Bangalore -560007

Mobile no :- 8971818167

Consent Form for patients

A STUDY OF THE MORPHOLOGY OF UPPER AERODIGESTIVE TRACT IN SUBJECTS WITH SNORING AND OBSTRUCTIVE SLEEP APNEA SYNDROME

______(Patient Particulars) has been fully informed of the nature and purpose of this study. Details of the procedure have been explained. All queries raised by the patient have been answered to the best of my ability. A signed copy of this form will be made available to the patient.

Student’s Signature:

Date:

I have been fully informed of the above noted study with its possible benefits, risks and consequences. I hereby agree to participate in this investigation. I furthermore recognize the fact that I am free to withdraw this consent and to discontinue my participation in this study at any time without prejudice to my care. I further consent to this data being used for research and /or publication provided confidentiality is maintained.

Signature:-

Name :-

Date :-