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Study Detail

Study ID 1003
Name Sleep and Asthma Cohort (SAC) Study
Contact Email m.debaun@vumc.org
Acronym SAC
Period 2006 - 2014
Design Observational cohort study
Study PI Michael R. DeBaun
Institution Vanderbilt University
URL NA
CTGovID NA
Funding Agency NHLBI
Grant Number 1R01HL079937-01
Overview The project will have three inter-related Aims: 1) To determine if asthma risk factors (parental history of asthma and positive skin test for an aeroallergen) are associated with an increase incidence of pain and ACS episodes. Aim 2, to determine relationship between SDB and the presence of, or progression to, obstructive lung disease. Aim 3, to determine the longitudinal relationship between the percentage and phenotypes of circulating fibrocytes and evolution of abnormal lung function. Together, the results of this highly interactive collaboration of clinical and basic scientists will permit new insights into the natural history and pathogenesis of lung and sleep disease in SCD, providing a strong foundation for future targeted therapy.
Focus Areas 1. Asthma phenotypes, as defined by bronchodilator response, obstructive pattern on spirometry, and doctor diagnosis of asthma
2. Restrictive lung disease (reduced total lung capacity determined on lung volume testing)
3. Characterize pulmonary function (based on Spirometry, bronchodilator response, in children with SCD
4. Determine linear growth curves in children with SCD with and without asthma
5. Determine the relative importance of sleep-disordered breathing and asthma in predicting nocturnal oxygen desaturation in children, adolescents and adults with SCD
6. Determine the relationship between asthma and sleep disordered breathing
7. Determine which patterns of nocturnal oxygen desaturation are risk factors for ACS
8. Evaluate the lung function of healthy normal control children using spirometry and lung volume testing to compare to the lung function of the children with SCD
9. Impact of hydroxyurea on lung growth in adults and children with SCD
Outcomes 1. Increased incidence of either vaso-occlusive pain episodes requiring hospitalization and treatment with opioids (Aim 1A) and/or acute chest syndrome (ACS) (Aim 1B) and progression of lung function abnormalities
2. Sleep disordered breathing (SDB) as measured by apnea, hypopnea and desaturation indices
3. Circulating fibrocyte number and activated phenotype (expression of pSmad2/3 or a-SMA)
Data Location Vanderbilt University Medical Center
Biospecimen Available N/A
Data Consent Research team will only use and share inforamtion discussed in consent form, de-identified.
Biospecimen Consent Blood and/or data for future research and sharing with other investigatiors at Washington University or other research centers. Blood/information will be deidentified. Blood/data will be used for this studies and may be used for future studies. Sharing and future use of blood/data is voluntary.
Contact Consent Yes, with permission on consent
Genomic Data No
Age Range 5-14
No. Participants 243
Inclusion Criteria 1. Patients with Sickle Cell Disease (HbSS, HbSC, HbSß-thal) + or HbSß-thal) zero) confirmed on hemoglobin analysis after 6 months of age or with other confirmatory documentation of phenotype such as hemoglobin analysis in both parents with complete blood cell counts.
2. Currently enrolled in SAC-I
3. Patients followed regularly in the outpatient hematology clinics.
4. Patients willing to be followed for at least three years.
5. Fully informed consent and assent.
Exclusion Criteria Subjects that are not enrolled in SAC I or those that did not meet the above inclusion criteria.
Study Documentation
  Select All
Protocol_Asthma_Nocturnal_Hypoxemia_Sickle_Cell_Anemia
Forms
  Select All
   1. Asthma_Medication
   2. CBC_Closest_To_eNO
   3. Ccontrol
   4. Celig
   5. Clab
   6. Echo_Crf10
   7. Elig
   8. Enroll
   9. Ess
   10. Event
   11. Hosp_Summary
   12. Ict
   13. Interim_Lab
   14. Interim_Meds
   15. Interimhx
   16. Lifetime_Pain_And_Acs
   17. Medhx_Int
   18. Missvisit
   19. MRI_Heart
   20. New_Interim_History_V11.10.2014
   21. Oximetry
   22. Participant
   23. Phlebot
   24. Pulcheck
   25. SAE
   26. Semtel
   27. Semtelmeds
   28. Shortpe
   29. Sleep
   30. Tonsillectomy_&_Adenoidectomy_Form
   31. Urine
   32. Withdrawal

Data ElementVariables
Substance Use cpsmoke
cpsmokeless
daysmoke
numcigar
smokecpd
smokedpw
smokelstv
smokepc
smokesh
smokeslv
smoking_q23
smoking_q24
smoking_q25
smoking_q26
Data ElementVariables
Acute Anemic Episode
Aplastic Crisis
Bleeding
Other Blood Problem
Sickle Cell Disease cpsick
diaghomosickle
SCD_DIAG
Data ElementVariables
Aneurysm
Cardiac Failure
Cardiovascular Problem
Heart Problem cdiagheart
Data ElementVariables
Gastrointestinal Problem cgerd
Hepatitis
Liver Problem
Data ElementVariables
Fever
HIV Infection hiv
Immune Problem
Infection
Vaccination
Data ElementVariables
Adverse event action_file
ae1
aecode1
aegrade1
descriptive_82
descriptive_88
event_typ
outcome
rpt_typ
sequelae
sequelae_othr
Death death_cause
death_cause_othr
death_date
death_loc
death_loc_othr
Disability Status
Hospitalization
Medical Event
Serious Adverse Event admit
ae_adm_date
ae_dis_date
desc_file
event_attrib
sae_doc_file
Data ElementVariables
Meningitis
Neurologic Event
Seizure descriptive_65
famsez
famsez1
sez
sez_assoc
Stroke descriptive_66
silstr
silstr_reason
silstr7
Transient Ischemic Attack
Data ElementVariables
Abdominal Pain
General Pain
Headache bedhead
descriptive_63
descriptive_64
descriptive_67
head
head2
head4
head5
head6
head7
head7d
heada1
heada3
headmig
othersp
rehead
rehead1
sevhead
sevhead1
sevhead2
sevhead3
sevhead9
sevheadneuro
simhead
simhead1
symhead
vissymp
Management admit_reason
chesynnum
hospainnum
hospainyn
other_explain
pain_admit
painepnum
painepyn
Pain Attack
Skeletal and Joint Pain
Data ElementVariables
Birth Outcome
Gestational Age ccontrol_clt35wks
celig_clt35wks
Menstruation
Pregnancy
Reproductive Behavior
Data ElementVariables
Acute Chest Syndrome acsvty
chesynyn
hosacsnum
hosacsyn
Asthma adsm28
diagasth
cdrdiagasth
Lung Disease ccf
cdiagcf
clungdis
cneonatallung
resp_hospnum
resp_hospyn
Other Respiratory Problem allergen
allergprob
allergylstv
atsdld_q1
atsdld_q10
atsdld_q11
atsdld_q12
atsdld_q13
atsdld_q13a
atsdld_q13b
atsdld_q13c
atsdld_q14
atsdld_q15
atsdld_q16
atsdld_q2
atsdld_q3
atsdld_q4
atsdld_q5
atsdld_q6
atsdld_q7
atsdld_q8
atsdld_q9
awakened
bothered
botheresp
breathnorm
ccold3wk
ccontrol_wheeze
chestex
chestexyn
chestsym
chospresp
congest
congestmostdays
congestncold
cough
coughmost
coughplay
coughwcold
coughwocold
degree
descriptive_54
eczemaslv
frqchestex
frqrespsym
playsymps
resplimit
ressympdays
ressympnights
sabprev
sabuse
sympfreq
wheezemed
wheezemost
wheezesob
wheezesob2
wheezewcold
wheezewocold
Data ElementVariables
Sleep Problem actsleep
amsymp1
amsymp10
amsymp11
amsymp2
amsymp3
amsymp4
amsymp5
amsymp6
amsymp7
amsymp8
amsymp9
asleep_ampm
awake
bed_ampm
bedroom
bedtime_ampm
breathnoisy
breathpro
caffein
caffeinamount
daydream
descriptive_100
descriptive_45
descriptive_46
descriptive_56
descriptive_57
descriptive_58
descriptive_59
descriptive_60
descriptive_99
fallasleep_ampmnon wd
fallsleep
fallsleeppro
finsomnia
fnarco
frestless
fslapnea
fsleeppro
fslterror
fsnor
grindteeth
hnap
hownoisy
incar
jerk
misschool
moring_21a
moring_q20a
mornbedoutpro
mornheadache
morning_19a
morning_19b
morning_19c
morning_19d
morning_19e
morning_19f
morning_19g
morning_19h
morning_19i
morning_19j
morning_19k
morning_20b
morning_20c
morning_21b
morning_21c
morning_napping
morning_napshrs
morning_napsnum
mornlongalert
mostsleep
nap
napaftrschool
naphrs
napnum
nightmare
nmoveawake
nnap
noibreday
nomovearm
nonap
nsbedt
nsrfslt
nswaket
outbed
ownbed
playgame
publicplace
rbed
resistbed
restafternoon
restless
sbedt
scream
sitquiet
sitread
sittalk
sleep_17a
sleep_17b
sleep_17d
sleep_17e
sleep_17f
sleep_17g
sleep_17h
sleep_17i
sleep_17j
sleep_17k
sleep_17l
sleep_17m
sleep_17n
sleep_17o
sleep_17p
sleep_17q
sleep_17r
sleep_17s
sleep_17t
sleep_q17c
sleep_q18
sleepschool
sleepsymp1
sleepsymp10
sleepsymp11
sleepsymp12
sleepsymp13
sleepsymp14
sleepsymp15
sleepsymp16
sleepsymp17
sleepsymp18
sleepsymp19
sleepsymp2
sleepsymp20
sleepsymp3
sleepsymp4
sleepsymp5
sleepsymp6
sleepsymp7
sleepsymp8
sleepsymp9
sleeptalk
sleeptimewkdys
sleeptimewknd
sleeptv
sleepwalk
sleepwkdys
sleepwknd
snore
snornois
srfslt
staybedpro
stopbreath
swaket
sweat
tvroom
uncomf
wake
wakenight
waketime_ampm
waketime_ampm_non wd
wakewkdys
wakewknd
watchtv
weak
wetbed
Data ElementVariables
Cardiovascular
Digestive
Genitourinary
Lymphatic
Musculoskeletal
Ocular
Respiratory event_adenoidate
event_tonsildate
adenoidage
adenoidectomy
adenoidectomy_yn
date_adenoidectomy
date_tonsillectomy
medhx_int_adenoid
medhx_int_adenoidat e
medhx_int_surgproc
medhx_int_tonsil
medhx_int_tonsildate
oth
othspe
tonsilage
tonsilectomy
tonsillectomy
sleep_adenoid
sleep_tonsil
surgerylstv
intubated
Surgery History breathtube
event_surgproc
other
otherspec
tubedate1
tubedate2
Data ElementVariables
Address
Age celig_cpdob
Ethnic Group
Gender csex
Language
National Origin
Nuclear Family
Race cprace1
Data ElementVariables
Annual Income yfi
Education grade
Employment Status
Household numge17
numlt17
Insurance ins
Marital Status
Data ElementVariables
Exposure adsm20
adsm21
adsm21a
adsm22
adsm22a
adsm23
adsm23a
adsm24
adsm24a
adsm25
adsm25a
adsm26
adsm27
canysmokenow
carsmoke
descriptive_61
freqcs
freqin
freqq
freqsm
hsmoke
ipp
live_w_smokers
outs1
smk1
smoke24
smokeshhpd
smokeshppw
smokewk
smoking_q27
smoking_q27a
smoking_q27b
Lead Poisoning
Data ElementVariables
Final Diagnosis hosrespnum
hosrespyn
icd1
icd2
icd3
reason_for_hospitaliz ation
Hospitalization dreason
dreason_othr
hosp
ICU cicn
icu
Data ElementVariables
Brain
Heart my_t2
pa_com
part_id
pk_tpv
ra_di
rv_edv
rv_ef
rv_esv
rv_fwt
rv_sv
ta_pse
tr_tr
tr_vol
bs_a
la_vol
lv_ed
lv_es
lv_fil
lv_ma
lv_stv
lv_tpfr
mpa_dim
Hip
Liver
Data ElementVariables
Demographics
Socioeconomic Status marstat
Data ElementVariables
Blood Differential Test basophil
basophil_eno
lymphocyte
lymphocyte_eno
monocyte
monocyte_eno
neutophil
neutophil_eno
retic_count
retic_count_eno
Blood Gases explain
iq
oxireading
oxysa
perfuindex
pulse
Blood Smear
Blood Typing cige
Coagulation Test
Complete Blood Count cmcv
crdw
credcell
eosinophil
eosinophil_eno
hbgdl
hbgdl_eno
hbmmol
hbmmol_eno
hemocrit
hemocrit_eno
platelet10l
platelet10l_eno
plateletkcum
plateletkcum_eno
wbc
wbc_eno
Comprehensive Metabolic Panel (CMP) interim_lab_ige
Enzyme interim_lab_ldh
phlebot_ldh
General cbc
rna
hemoanaly
Hemoglobin Electrophoresis basehemo
cbasehemo
chba
chba2
chbgdl
csickscree
Iron
Data ElementVariables
Genitourinary Test
Urine Test amounturine
urine_comment
urinetime
Data ElementVariables
Abdomen
Anthropometrics avgsitht
calibrate
height1
height2
height3
heightave
pulcheck_weight
shortpe_weight
sitht1
sitht2
sitht3
stheight
Cardiovascular
Extremities
General appear
shortpe_int_tonsil
tngper
tngrest
descriptive_96
descriptive_97
descriptive_98
Liver
Reproductive
Respiratory descriptive_94
descriptive_95
air
cough_othr
wheeze_othr
rales
rales_othr
retract
shortpe_wheeze
Spleen
Vital signs hr
pulcheck_temp
rb1_dia
rb1_sys
rb2_dia
rb2_sys
rb3_dia
rb3_sys
rb4_dia
rb4_sys
rr
shortpe_temp
Data ElementVariables
Pulmonary Function Test caffeine4hr
cold2wk
continue_testing
eatdrink1hr
fever
longbrodilator12hr
lungschedule
narcs
pain
shbrodilator4hr
smoke
smoke1hr
symptom24hr
theophy24hr
Respiratory Test
Data ElementVariables
Antibiotics
Asthma conf_asth_dx
descriptive_91
flovent
flovent_dose
flovent_off
flovent_start
flovent_stop
newmed
numsteroid
o2pmliters
other_asthma_name
other_dose2_579
other_start2_7d0
other_stop2_014
oxliters
hydstartdate
hydstop
hydstopdate
interim_meds_freq
med_restart
med_restart10
med_restart12
med_restart3
med_restart5
med_stop
medication_restart16
medication_stop
medication_stopped1 3
medication_stopped8
pulmicort
pulmicort_dose
pulmicort_off
pulmicort_restarted
pulmicort_retart_date 5
pulmicort_start
pulmicort_stop
pulmicort_stop_date
pulmicort_stopped
qvar_off
qvar_restart
qvar_restart_date
qvar_restarted
qvar_restarted15
qvar_stop_date
qvar_stopped
restart_date
restart_date11
restart_date14
restart_date17
restart_date2
restart_date4
restart_date6
dulera_restartdate4
dulera_restarted
dulera_restarted3
dulera_startdate
dulera_startdose
dulera_stopdate
dulera_stopdate2
dulera_stopped
dulera_stopped1
dulera_yesno
dylera_restartdate
azmacort_dose
azmacort_restared3
azmacort_restartdate
azmacort_restartdate 4
azmacort_restarted
azmacort_start_date
azmacort_stopdate
azmacort_stopdate2
azmacort_stopped
azmacort_stopped1
azmacort_yesno
advair
advair_dose
advair_off
advair_start
advair_stop
aerobid_dose
aerobid_restartdate
aerobid_startdate
aerobid_stopdate
aerobid_stopped
aerobid_stopped2
aerobid_yesno
albutbfex
albutresp
aleveso_yes_no
alvesoco_dose
alvesoco_restart1
alvesoco_restart5
alvesoco_restartdate2
alvesoco_restartdate6
alvesoco_startdate
alvesoco_stopdate
alvesoco_stopdate4
alvesoco_stopped
alvesoco_stopped3
areobid_restartdate4
areobid_restarted
areobid_restarted3
areobid_stopped1
asmanex_restart_dat e2
asmanex_restartdate 5
asmanex_restarted1
asmanex_restarted4
asmanex_startdate
asmanex_startdose
asmanex_stopdate
asmanex_stopdate3
asmanex_stopped
asmanex_stopped2
asmanex_yesno
steroidlstv
stop_date
stop_date15
stop_date9
symbicort
symbicort_dose
symbicort_restart
symbicort_restart_dat e
symbicort_restart_date
symbicort_start
symbicort_stop
symbicort_stop_date
symbicort_stopped
symbicort_yes
symicort_restart_date
symicort_restarted
singulair
singulair_dose
singulair_off
singulair_start
singulair_stop
Blood Medication History
Cardiovascular
Compliance
Current Medication
Depression Medication History
Hydroxyurea hydroxstart
hydroxstartdate
hydroxstop
hydroxstopdate
hydstart
Medication descriptive_55
descriptive_93
interim_meds_dose
interim_meds_medna me
interim_meds_rxnow
rxos
rxostimes
semtelmeds_dose
semtelmeds_freq
semtelmeds_medna me
semtelmeds_rxnow
Neurologic Medication History
Pain medhead
medhead1
medhead2
medhead3
medhead4
medhead5
SCD Medication
Sildenafil
Supplements
Data ElementVariables
Blood Transfusion transflstv
Chronic Transfusion cbtt
chronblood
medhx_transfusionda te
transfusion_date
transfusion_dateeven t
transfusion_hx
Transfusion Complications
Data ElementVariables
Oxygen o2pm
oxther
Treatment
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