Does Sound Conditioning Protect Against Temporary Hearing Damage
Conditions: Hearing Loss, Noise-Induced
Sponsor: Imperial College Healthcare NHS Trust

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Does  Sound  Conditioning  Protect  Against  Temporary  Hearing  Damage?    
  
  
  
  
  
Research  Protocol  
Version  8  
Date  08/07/2019  
  
  
  
MAIN  SPONSOR:  Imperial  College  Healthcare  NHS  Trust  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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Study  Management  Group  
Chief  Investigator:  Emily  Frost  
Co-­investigators:  Hemna  Santilale  
Study  Supervisor:  Prof.  Chris  Plack  
Study  Management:  Emily  Frost  
  
Study  Coordination  Centre    
  
For  general  queries,  supply  of  study  documentation,  and  collection  of  data,  please  contact:  
  
Study  Coordinator:  Hemna  Santilale  (Trainee  Clinical  Scientist)  
  
Address:  Imperial  College  Healthcare  NHS  Trust  
      Audiology  Department  
  
      Charing  Cross  Hospital    
  
      Fulham  Palace  Road  
  
        W6  8RF  
  
  
  
  
  
  
    
Tel:  
02033111020     
  
  
  
  
  
  
E-­mail:    hemna.santilale@nhs.net  
  
Clinical  Queries  
  
Clinical  queries  should  be  directed  to  Hemna  Santilale  who  will  direct  the  query  to  the  appropriate  
person.  
  
Sponsor  
  
Imperial  College  Healthcare  NHS  Trust  is  the  main  research  Sponsor  for  this  study.    For  further  
information   regarding   the   sponsorship   conditions,   please   contact   the   Head   of   Regulatory  
Compliance  at:  
Joint  Research  Compliance  Office  
Imperial  College  London  and  Imperial  College  Healthcare  NHS  Trust  
Room  215,  Level  2,  Medical  School  Building  

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Norfolk  Place  
London,  W2  1PG  
Tel:  0207  594  9459/  0207  594  1862  
http://www3.imperial.ac.uk/clinicalresearchgovernanceoffice    
  
Funder  
This  research  project  is  part  of  a  MSc.  project  within  the  Scientist  Training  Programme.    
  
This   protocol   describes   this   study   and   provides   information   about   procedures   for   entering  
participants.   Every   care   was   taken   in   its   drafting,   but   corrections   or   amendments   may   be  
necessary.  These  will  be  circulated  to  investigators  in  the  study.    Problems  relating  to  this  study  
should   be   referred,   in   the   first   instance,   to   the   Chief   Investigator.   This   study   will   adhere   to   the  
principles  outlined  in  the  UK  Policy  Frame  "Work  for  Health  and  Social  Care  Research.”    It  will  be  
conducted   in   compliance   with   the   protocol,   the   Data   Protection   Act   and   other   regulatory  
requirements  as  appropriate.  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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Table	  of	  Contents	  
1.	  
INTRODUCTION	  ..................................................................	  6	  
1.1	  
Background	  ......................................................................................	  6	  
2.    	  
STUDY  OBJECTIVES	  .........................................................	  7	  
3.    	  
STUDY  DESIGN	  ...................................................................	  7	  
3.1	  
Study	  Outcome	  Measures	  ................................................................	  8	  
3.2	  
Methods	  ...........................................................................................	  8	  
4.	  
PARTICIPANT  ENTRY	  ........................................................	  9	  
4.1	  
Consent	  ............................................................................................	  9	  
4.3	  
Inclusion	  Criteria	  ..............................................................................	  9	  
4.4	  
Exclusion	  criteria	  ............................................................................	  10	  
4.5	  
Withdrawal	  criteria	  ........................................................................	  10	  
5.  	  
ADVERSE  EFFECTS	  ........................................................	  10	  
5.1	  
Definitions	  ......................................................................................	  10	  
5.2	  
Reporting	  Procedures	  .....................................................................	  10	  
5.2.1	  	  
NON	  SERIOUS	  AEs	  ............................................................................	  11	  
5.2.2	  	  
SERIOUS	  AEs	  .....................................................................................	  11	  
6.  	  
ASSESSMENT  AND  FOLLOW-­UP	  ..................................	  11	  
7.	  
STATISTICS  AND  DATA  ANALYSIS	  ..............................	  11	  
8.	  
REGULATORY  ISSUES	  ....................................................	  12	  
8.1	  
Ethics	  approval	  ...............................................................................	  12	  
8.3	  
Confidentiality	  ................................................................................	  12	  
8.4	  
Indemnity	  .......................................................................................	  12	  
8.5	  
Sponsor	  ..........................................................................................	  12	  
8.6	  
Audits	  .............................................................................................	  12	  
9.	  
STUDY  MANAGEMENT	  ....................................................	  12	  
10.	  
PUBLICATION  POLICY	  ....................................................	  13	  
11.	  
REFERENCES	  ...................................................................	  13	  
  
  
  
  
  
  
  
  
  
  
  
  

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GLOSSARY  OF  ABBREVIATIONS  
  
PTA  
Pure  Tone  Audiometry  
DPOAE  
Distortion  Product  Otoacousic  Emissions  
MEMR  
Middle  Ear  Muscle  Reflex  
EHF  
Extended  High  Frequency  
TFI  
Tinnitus  Functional  Index  
SiN  
Speech  in  Noise  
HL  
Hearing  Loss  
NIHL  
Noise  Induced  Hearing  Loss  
WHO  
World  Health  Organisation  
NESI  
Noise  Exposure  Structure  Interview  
  
  
  
STUDY  SUMMARY  
  
TITLE  
Does  Sound  Conditioning  Protect  Against  Temporary  Hearing  Damage?  
DESIGN  
Between  Groups  Trial  
AIMS  
To   investigate   if   previous   sound   conditioning   reduces   susceptibility   to   TTS   and  
tinnitus  when  comparing  to  those  without  prior  exposure  
OUTCOME  MEASURES  
EHF  PTA,  DPOAE,  MEMR,  TFI,  SiN  Test  
POPULATION  
40  Normal  Hearing,  Healthy  18-­35  year  olds  
DURATION  
July  2019  –  May  2020  
  
  
  
  
  
  
  
  
  
  
  
  
  

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1.  
INTRODUCTION    
  
1.1  
BACKGROUND  
This  research  project  will  contribute  to  the  research  surrounding  the  effect  on  the  cochlea  after  noise  
exposure;;   this   ever   growing   field   of   research   has   never   been   more   applicable   than   now   with   the  
increase  of  recreational  noise  exposure.    
  
Hearing  Loss  (HL)  is  becoming  more  prevalent  in  today’s  world,  and  is  the  most  common  sensory  
deficit.  Over  5%  of  the  world’s  population,  over  360  million  people,  have  disabling  HL  (World  Health  
Organisation  [WHO],  2015).  This  is  defined  by  WHO  as  a  moderate  HL  where  hearing  thresholds  
are  greater  than  40  dB  HL.  This  figure  is  expected  to  be  closer  to  900  million  by  2050.  In  the  U.K.  
alone,   latest   figures   suggest   one   in   six   of   the   population   have   some   form   of   HL.   By   2035,   it   is  
estimated  that  this  will  increase  to  one  in  five  (Action  on  Hearing  Loss  [AoHL],  2016).    
  
Noise  is  the  leading  cause  of  preventable  hearing  loss  and  second  only  to  presbycusis  (age-­related  
hearing   loss)   for   the   most   common   sensorineural   hearing   deficit.   Excessive   occupational   noise  
along  with  recreational  noise  exposure  can  cause  a  devastating  disability.  In  a  world  where  cities  
never  sleep,  traffic  never  stops,  phones  require  devotion  and  there  is  constant  noise  coming  from  all  
directions,   it   is   no   surprise   that   noise   itself   is   one   of   the   most   common   pollutants.   Generally,  
environmental  sounds  are  at  safe  levels  but  sounds  can  become  harmful  when  too  loud  and  worse  
when  they  are  long-­lasting  too.  As  noise  damage  usually  occurs  gradually  early  in  life,  it  is  typically  
not  perceived  until  it  worsens  with  age  and  becomes  more  pronounced  and  noticeable.  At  this  stage  
it  can  cause  worse  debilitating  effects  i.e.  social  isolation.  In  recent  research,  there  is  much  more  
focus  concerning  young  people  and  excessive  exposure  to  recreational  noise.  On  the  3rd  of  March  
2018,  World  Hearing  Day  (WHO)  focused  on  ‘Hear  the  future’  to  highlight  preventative  measures  
and   management   strategies   to   address   the   anticipated   rise   in   hearing   loss   prevalence   globally.  
WHO   estimates   1.1   billion   young   people   could   be   at   risk   of   hearing   loss   due   to   unsafe   practice  
listening  practices.    
  
Currently,  understanding  of  NIHL  is  unclear.  There  is  a  reliance  on  clinical  Pure-­Tone  Audiometry  
(PTA)  results  typically  from  0.25  Hz  to  8  kHz  to  reveal  a  characteristic  dip/notch  in  the  audiogram  
between  3  kHz  and  6  kHz.    An  expansion  of  knowledge  and  understanding  of  how  noise  exposure  
impacts  hearing  is  required,  in  order  to  have  better  preventative  measures  and  treatments  in  place.    
  
1.2  
RATIONALE  FOR  CURRENT  STUDY  
One   of   the   mechanisms   shown   to   increase   the   resistance   against   Noise   Induced   Hearing   Loss  
(NIHL)  is  ‘sound  conditioning’.  Animal  studies  have  found  that  prior  exposure  to  low  level  noise  over  
a  period  of  a  few  weeks  can  'condition'  the  ear.  This  conditioning  then  reduces  the  susceptibility  to  

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high  level  exposure  i.e.  strengthening  the  cochlea.  However,  the  underlying  mechanisms  are  not  yet  
clarified.  This  conditioning  may  be  related  to:  increased  levels  of  antioxidant  enzymes,  neurotropic  
factors,  inhibition  of  apoptosis  along  with  many  other  speculations.  Speculation  has  also  occurred  
with  regards  to  conditioning  acting  systemically  or  locally.   Animal  studies  in  regards  to  NIHL  and  
conditioning   suggest   with   prior   exposure   there   is   less   risk   than   those   with   little   exposure   before  
experiencing  one  high  exposure  event.  There  are  gaps  however  in  the  knowledge  on  the  effects  of  
conditioning  in  humans.  A  study  where  humans  are  tested  prior  and  post  a  high-­exposure  event  with  
varying  previous  noise  exposure  history  ('conditioning')  is  not  yet  available.  The  relations  between  
temporary   threshold   shift   (TTS),   speech   in   noise,   tinnitus,   and   sex   are   currently   unknown   and  
require  further  investigation.  
  
There  are  many  implications  of  this  research.  For  one  it  will  allow  us  to  understand  more  about  the  
susceptibility  to  exposure  of  sounds  and  the  resistance  against  NIHL.  This  will  mean  that  we  can  
enable  appropriate  interventions  if  necessary.  For  example,  an  individual  who  is  more  susceptible  
due   to   low   prior   exposure   may   be   advised   that   they   are   at   risk,   and   encouraged   to   use   hearing  
protection.  We  will  be  able  to  learn  more  about  the  impacts  of  noise  with  hearing  and  educate  others  
such  as  understanding  the  impacts  from  high-­level  exposure.    
  
2.      
STUDY  OBJECTIVES  
  
i)  
To   identify   if   there   is   a   relationship   between   previous   sound   exposure   levels   and   TTS   and  
tinnitus  after  a  single  loud  noise  event.  
  
3.      
STUDY  DESIGN  
  
Type  of  Study:  Basic  Science  Study,  Between  Groups  Trial  
Aim:  To  investigate  if  previous  sound  conditioning  reduces  susceptibility  to  TTS  and  tinnitus  when  
  
comparing  to  those  without  prior  exposure.  
Purpose:  To  increase  our  understanding  on  the  effects  of  noise  exposure.  
Duration:  Data  collection  will  be  completed  by  February  2020  
Participants:   40   normal   hearing   young   (18-­35)   participants   in   good   general   health   and   fluent   in  
English.    
Spilt  into  groups  of  two.  One  group  (20,  10f:10m)  with  previous  exposure  i.e.  nightclubs  ++,  
the  other  group  (20,  10f:10m)  with  less  exposure  measured  through  NESI.      
  

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3.1  
STUDY  OUTCOME  MEASURES  
The  participants  will  need  to  attend  three  sessions  which  will  take  approximately  35  minutes,  105  
minutes  overall.  Participants  will  be  required  to  attend  testing  before,  after  a  high  exposure  event  
they   would   usually   find   themselves   in,   and   a   week   later   to   test   recovery.   The   results   will   be  
evaluated   and   available   on   request   by   04/04/2020.   The   outcome   measures   are   the   Extended  
Frequency  (EF)  PTA,  Distortion  Product  Otoacousic  Emissions  (DPOAE),  Tinnitus  Functional  Index  
(TFI),  Middle  Ear  Muscle  Reflex  (MEMR)  and  Speech  in  Noise  (SiN)  Test.  
  
3.2  
METHODS  
  
Screening  -­  Participants  will  be  asked  about  the  health  of  their  ears  and  ears  will  be  examined  to  
ensure  there  are  no  abnormalities  (Otoscopy).  A  hearing  test  (PTA)  will  then  be  performed;;  This  test  
will   involve   participants   listening   to   a   series   of   tones   at   different   pitches   and   volumes   through  
headphones  and  participants  will  press  a  button  whenever  they  hear  a  tone.  The  researcher  will  also  
undertake  a  structured  interview  to  assess  noise  exposure  history  (NESI)  and  the  results  from  the  
screen   will   see   if   you   are   eligible   to   participate   in   this   research.   With   participants   consent,   if   any  
abnormalities   are   detected   at   any   point,   your   GP   will   be   informed   with   a   copy   of   the   results.  
Participants  will  subsequently  be  excluded  from  the  study  and  information  destroyed.  Example  of  
NESI   question:   I’d   like   you   to   estimate   how   noisy   it   was   when   you   [engaged   in   the   activity]   by  
answering  this  question:  If  you  and  I  were  4  feet  apart  in  that  situation,  which  of  the  following  would  
you  need  to  do  to  communicate  with  me?  [The  interviewer  presents  the  six  options  from  the  Speech  
Communication  Table.]    
  
Each  session  will  require  35  minutes  (35  x  3  =  105  minutes  overall).  
  
SESSION  ONE  -­  Prior  to  noise  exposure  (continued  same  day  after  screening  passed  if  eligible):  
Test   battery   -­   High   frequency   audiometry,   Distortion   Product   Otoacousic   Emissions,   Middle   Ear  
Muscle  Reflex,  Speech  in  Noise  test,  Tinnitus  Functional  Index  (Around  35  minute  testing  time  with  
breaks  if  required)  
•   Extended  Frequency  Pure  Tone  Audiometry  (~  8  minutes)  
Similar  to  Screening,  participants  will  be  asked  to  press  the  button  when  they  hear  a  sound  through  
the  headphones  in  a  sound  proof  booth.  
•   Distortion  Product  Otoacoustic  Emissions  (~  5  minutes)  
A   small   tip   will   be   placed   in   participants'   ear   and   they   will   hear   a   sound.   The   tip   measures   a  
response  from  hair  cells  in  the  cochlea  and  they  will  not  need  to  do  anything.  
•   Middle  Ear  Muscle  Reflex  (~  8  minutes)  
A  small  tip  will  be  placed  in  both  ears  and  again  a  sound  heard  however  this  sound  will  gradually  get  
louder  until  an  involuntary  muscle  reflex  is  noted.  

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•   Speech  in  Noise  Test  (~  5  minutes)  
Participants  will  be  asked  to  repeat  back  a  list  of  words  as  best  as  they  can.  
•   Tinnitus  Functional  Index  (~  8  minutes)  
Participants  will  be  given  a  self-­report  sheet  in  which  they  have  to  fill  out  aspects  of  any  tinnitus  
experienced.  
  
SESSION  TWO  -­  Exposure  at  single  loud  music  event  (Important  that  this  is  part  of   participants'  
normal  recreational  routine,  and  specifically  require  that  attendance  is  not  prompted  by  participation  
in   this   study):   Participants   to   use   sound   level   meter   provided   from   the   Audiology   Department   at  
Charing  Cross  Hospital  to  measure  sound  levels  inside  the  loud  event.  
Morning  after  exposure:  Repeat  test  battery  from  session  one  -­  Ideally  as  soon  as  event  is  over.  
  
SESSION  THREE:  1  week  later  (recovery):  Repeat  test  battery.  
  
4.  
PARTICIPANT  ENTRY    
  
  
A  poster  will  be  used  in  the  waiting  area  and  staff  room  of  the  Audiology  department  at  Charing  
  
Cross  Hospital.  This  poster  will  also  be  used  on  social  media.  
  
4.1  
CONSENT  
Consent  to  enter  the  study  must  be  sought  from  each  participant  only  after  a  full  explanation  has  
been   given,   an   information   leaflet   offered   and   time   allowed   for   consideration.      Signed   participant  
consent  should  be  obtained.  Participants  will  be  provided  the  consent  form  and  information  sheet  via  
email   or   directly   (meeting   organised   over   the   phone   –   Audiology   department   at   Charing   Cross  
Hospital).   They   will   be   given   a   minimum   of   24   hours   and   maximum   of   7   days   to   contact   the  
researcher  to  go  ahead  with  the  study  and  a  date  will  be  organised  to  sign  the  consent  form  and  
begin   screening.   In   this   time,   participants   can   also   ask   any   questions   they   may   have   to   the  
researcher   via   email   or   phone.   The   right   of   the   participant   to   refuse   to   participate   without   giving  
reasons   must   be   respected.   All   participants   are   free   to   withdraw   at   any   time   from   the   protocol  
treatment  without  giving  reasons  and  without  prejudicing  further  treatment.    
  
4.3  
INCLUSION  CRITERIA  
•  
18-­35  years  old  (as  age  can  affect  cochlea  hair  cell  function)  
•  
Healthy  participants  with  no  significant  medical  conditions  
•  
0.25  Hz  to  8  kHz  PTA  in  both  ears  have  thresholds  <  20  dB  HL  indicating  normal  hearing  
•  
Otoscopy  to  ensure  no  otological  abnormalities    
•  
No  exposure  to  abnormally  loud  sounds  in  the  past  24  hours    
•  
Full  capacity  to  consent  

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•  
Able   to   speak   fluent   English   so   information   sheets,   consent   forms   and   instructions   are   fully  
understood  
•  
Previous  intention  to  attend  a  loud  noise  event  during  the  course  of  the  study,  without  the  use  of  
hearing  protection  
  
4.4  
EXCLUSION  CRITERIA  
•  
No  permanent  tinnitus  or  hyperacusis  (sensitivity  to  loud  sounds)  which  would  mean  participants  are  
unable  to  undertake  all  testing  and  a  high  exposure  event    
•  
Any  contraindications  for  testing  i.e.  excessive  wax,  infections    
•  
One  or  more  frequencies  0.25  Hz  to  8  kHz  >  20  dB  HL  in  either  ear    
•  
Not  involved  in  current  research  or  have  recently  been  involved  in  any  research  prior  to  recruitment  
  
4.5  
WITHDRAWAL  CRITERIA  
A  consent  form  will  be  obtained  prior  to  commencing  the  study  however  participants'  may  withdraw  
at  any  time  by  notifying  the  researcher  in  person  or  in  written  form  and  without  providing  any  reason.    
  
5.    
ADVERSE  EFFECTS    
  
5.1  
DEFINITIONS  
Adverse  Event  (AE):  any  untoward  medical  occurrence  in  a  patient  or  clinical  study  subject.      
Serious  Adverse  Event  (SAE):  any  untoward  and  unexpected  medical  occurrence  or  effect  that:  
•   Results  in  death  
•   Is  life-­threatening  –  refers  to  an  event  in  which  the  subject  was  at  risk  of  death  at  the  time  of  the  
event;;  it  does  not  refer  to  an  event  which  hypothetically  might  have  caused  death  if  it  were  more  
severe  
•   Requires  hospitalisation,  or  prolongation  of  existing  inpatients’  hospitalisation  
•   Results  in  persistent  or  significant  disability  or  incapacity  
•   Is  a  congenital  anomaly  or  birth  defect  
  
Medical   judgement   should   be   exercised   in   deciding   whether   an   AE   is   serious   in   other   situations.    
Important  AEs  that  are  not  immediately  life-­threatening  or  do  not  result  in  death  or  hospitalisation  
but  may  jeopardise  the  subject  or  may  require  intervention  to  prevent  one  of  the  other  outcomes  
listed  in  the  definition  above,  should  also  be  considered  serious.  
  
5.2  
REPORTING  PROCEDURES  
  
All  adverse  events  will  be  reported.    Depending  on  the  nature  of  the  event  the  reporting  procedures  
below  should  be  followed.    Any  questions  concerning  adverse  event  reporting  should  be  directed  to  
the  Principal  Investigator  in  the  first  instance.      

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5.2.1    
NON  SERIOUS  AEs  
  
All  such  events,  whether  expected  or  not,  will  be  recorded.      
5.2.2     SERIOUS  AEs  
An  SAE  form  should  be  completed  and  faxed  to  the  Chief  Investigator  within  24  hours.    However,  
and  hospitalisations  for  elective  treatment  of  a  pre-­existing  condition  do  not  need  reporting  as  SAEs.  
All  SAEs  should  be  reported  to  Ethics  Committee  where  in  the  opinion  of  the  Principal  Investigator,  
the  event  was:  
•  ‘related’,  ie  resulted  from  the  administration  of  any  of  the  research  procedures;;  and  
•  ‘unexpected’,  ie  an  event  that  is  not  listed  in  the  protocol  as  an  expected  occurrence  
Reports  of  related  and  unexpected  SAEs  should  be  submitted  within  15  days  of  the  Chief  Investigator  
becoming  aware  of  the  event,  using  the  NRES  SAE  form  for  non-­IMP  studies.    The  Chief  Investigator  
must  also  notify  the  Sponsor  of  all  SAEs.  
Local  investigators  should  report  any  SAEs  as  required  by  their  Local  Research  Ethics  Committee,  
Sponsor  and/or  Research  &  Development  Office.  
Contact  details  for  reporting  SAEs  
Fax.  attention  Emily  Frost  
Please  send  SAE  forms  to:    
Charing  Cross  Hospital  Audiology  Department  
Fulham  Palace  Road,  
London  
W6  8RF  
Tel:02033111024  (Mon  to  Fri  09.00  –  17.00)  
  
  
6.    
ASSESSMENT  AND  FOLLOW-­UP    
Participants  will  receive  a  week  post-­exposure  test  battery  to  assess  recovery.  After  this,  there  will  
be   no   follow   up   in   the   Audiology   Department.   If   abnormal   results   are   highlighted   at   any   stage,  
participants  will  be  excluded  from  the  study  and  as  consented,  a  letter  containing  the  results  will  be  
sent   to   the   GP.   Participants   will   subsequently   be   excluded   from   the   study   and   information  
destroyed.  
  
7.  
STATISTICS  AND  DATA  ANALYSIS  
The   quantitative   data   will   be   analysed   by   the   researcher   at   Charing   Cross   Hospital,   Imperial  
Healthcare  NHS  Trust.  Data  and  all  appropriate  documentation  will  be  stored  for  a  minimum  of  5  
years  after  the  completion  of  the  study,  in  line  with  trust  protocol.      
  
  

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8.  
REGULATORY  ISSUES  
  
8.1  
ETHICS  APPROVAL  
The  Study  Coordination  Centre  has  obtained  approval  from  the  Research  Ethics  Committee  (REC)  
and   Health   Research   Authority   (HRA).   The   study   must   also   receive   confirmation   of   capacity   and  
capability   from   each   participating   NHS   Trust   before   accepting   participants   into   the   study   or   any  
research   activity   is   carried   out.   The   study   will   be   conducted   in   accordance   with   the  
recommendations  for  physicians  involved  in  research  on  human  subjects  adopted  by  the  18th  World  
Medical  Assembly,  Helsinki  1964  and  later  revisions.  
  
8.3  
CONFIDENTIALITY  
The  Principal  Investigator  will  preserve  the  confidentiality  of  participants  taking  part  in  the  study.  All  
information  which  is  collected  during  the  research  will  be  kept  strictly  confidential.  Participants  will  
be  given  a  unique  ID  number  as  a  substitute  for  personal  information  and  this  will  be  attached  to  any  
results  from  tests.  This  will  be  kept  in  compliance  with  the  Data  Protection  Act.  This  anonymised  
data   will   be   stored   and   may   be   published.   Any   other   personal   information   will   be   stored   on   a  
password-­protected   database   and   only   accessible   to   the   Principle   Investigator.   This   will   be   kept  
separately  from  documentation  of  results,  ensuring  information  is  not  matched  and  avoid  accidental  
identification.  The  NESI  Structured  Interview  will  be  recorded  on  a  digital  device  and   transcribed;;  
any  recorded  data  will  then  be  destroyed  from  the  digital  device.  All  of  the  data  will  be  kept  for  5  
years  as  per  study  policies.  
  
8.4  
INDEMNITY  
  
Imperial  College  Healthcare  NHS  Trust  holds  standard  NHS  Hospital  Indemnity  and  insurance  cover  
  
with  NHS  Litigation  Authority  for  NHS  Trusts  in  England,  which  apply  to  this  study.  
  
8.5  
SPONSOR  
Imperial  College  Healthcare  NHS  Trust  will  act  as  the  main  Sponsor  for  this  study.    
  
8.6  
AUDITS    
The  study  may  be  subject  to  inspection  and  audit  by  Imperial  College  Healthcare  NHS  Trust  under  
their   remit   as   Sponsor,   the   Study   Coordination   Centre   and   other   regulatory   bodies   to   ensure  
adherence  to  GCP.  
  
9.  
STUDY  MANAGEMENT  
The  day-­to-­day  management  of  the  study  will  be  co-­ordinated  through  the  Principal  Investigator.  
  

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10.  
PUBLICATION  POLICY  
The  results  will  be  included  in  the  final  MSc  Project  and  in  ethical  applications  for  the  secondary  
phase,  where  the  evaluation  will  take  place.  The  results  will  be  published  in  peer  reviewed  journals,  
conference  papers  and  research  presentations.  The  anonymity  of  the  participants  will  be  ensured  
when  publishing.  If  participants  wish  to  receive  a  summary  report  of  the  findings  at  the  end  of  the  
study  then  they  may  request  this.    
  
All   publications   and   presentations   relating   to   the   study   will   be   authorised   through   the   Chief  
Investigator  and  Academic  supervisor.    If  there  are  named  authors,  these  will  include  at  least  the  
trial’s   Chief   Investigator,   Statistician   and   Trial   Coordinator.      Members   of   the   TMG   and   the   Data  
Monitoring  Committee  will  be  listed  and  contributors  will  be  cited  by  name  if  published  in  a  journal  
where  this  does  not  conflict  with  the  journal’s  policy.    Authorship  of  parallel  studies  initiated  outside  
of  the  Trial  Management  Group  will  be  according  to  the  individuals  involved  in  the  project  but  must  
acknowledge  the  contribution  of  the  Trial  Management  Group  and  the  Study  Coordination  Centre.  
  
11.  
REFERENCES  
ALTSCHULER  R.A,  ET  AL  (1996).  'Protective  mechanisms  in  the  cochlea:  Heat  shock  proteins.'  Auditory  
System  Plasticity  and  Regeneration.  Stuttgart:  Thieme  Medical  Publishers;;  1996.  p.  202-­12.    
HOWGATE,  STELLA.  PLACK,  CHRISTOPHER  J.  (2011)  'A  behavioural  measure  of  the  cochlear  changes  
underlying  temporary  threshold  shifts'  Audiology  Department,  Sunderland  Royal  Hospital,  UK.   
KUJAWA  SHARON  G.  &LIBERMAN  M.  CHARLES  (1997)  'Conditioning-­Related  Protection  From  Acoustic  
Injury:  Effects  of  Chronic  Differentiation  and  Sham  Surgery'  Department  of  Otology  and  Laryngology,  Harvard  
Medical  School,  and  Eaton-­Peabody  Laboratory,  Massachusetts  Eye  and  Ear  Infirmary    
MCFADDEN  S.L.,  HENDERSON  DONALD,  SHEN  YUN-­HUA  (1996)  'Low-­frequency  'conditioning'  provides  
long-­term  protection  from  noise-­induced  threshold  shifts  in  chinchillas'  Hearing  Research  Laboratories,  215  
Parker  Hall,  State  University  of  New  York  at  Buffalo,  Buffalo,  NY  14214-­3007,  USA.   
POURBAKHT  A,  YAMASOBA  T.  (2003)  'Cochlear  damage  caused  by  continuous  and  intermittent  noise  
exposure'  Hear  Res2003;;  178(1-­2):70-­8. PRENDERGAST  ET  AL.  'Effects  of  noise  exposure  on  young  adults  
with  normal  audiograms  I:  Electrophysiology  (2016)  and  II:  Behavioural  Measures  
(2017)'doi.org/10.1016/j.heares.2017.10.007.    
POURBAKHT  AND  IMANI  (2012)  'The  Protective  Effect  of  Conditioning  on  Noise-­Induced  Hearing  Loss  Is  
Frequency-­Dependent'  Acta  Medica  Iranica,  2012;;  50(10):  664-­669.   
WOJTCZAK  M,  JORDAN  A.  BEIM  AND  ANDREW  J.  OXENHAM  (2017)  'Muscle  Reflex  in  Humans  with  Noise-­
Induced  Tinnitus  and  Normal  Hearing  May  Reflect  Cochlear  Synaptopathy'  4  (6)  ENEURO.0363-­17.2017.    
ZUO  H  ET  AL  (2008).  'Changes  in  Guinea  pig  cochlear  hair  cells  after  sound  conditioning  and  noise  exposure'.  
J  Occup  Health  2008;;50(5):373-­9.