Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multi-center Clinical Trial of Limiting Resident Work Hours on ICU Patient Safety
Brief Summary: In this proposal, we seek to address conclusively two knowledge gaps: 1) the lack of data on the relationship between PGY2+ (post graduate year 2) sleep deprivation and patient safety; and 2) the lack of data on the relationship between resident sleep deprivation and preventable patient injuries. Through the Clinical and Translational Science Award (CTSA)-funded Sleep Research Network, the largest and only federally-funded sleep science network in the U.S., we propose conducting a multi-center randomized crossover trial in six pediatric ICUs staffed by PGY2 and PGY3 residents. We will compare rates of all serious errors (i.e., rates of harmful and other serious medical errors due to any cause, including but not limited to fatigue-related errors, handoff errors, and provider knowledge deficits) of a sleep and circadian science-based (SCS) intervention schedule with a traditional schedule that includes frequent shifts of 24 hours or longer. Our specific aims will be:

1. To test the hypothesis that PGY2\&3 residents working on an SCS intervention schedule will make significantly fewer harmful medical errors (preventable adverse events) and other serious medical errors (near misses) while caring for ICU patients than residents working on a traditional schedule; (primary endpoints: resident-related preventable adverse events and near misses)
2. To test the hypothesis that rates of harmful medical errors (preventable adverse events) and other serious medical errors (near misses) throughout the ICU (i.e., those involving and those not involving residents) will be lower in ICUs when PGY2\&3 residents work on an SCS intervention schedule than when residents work on a traditional schedule; (major secondary endpoints: ICU-wide preventable adverse events and near misses)
3. To test the hypothesis that resident physicians' risk of neurobehavioral performance failures and motor vehicle crashes - as assessed through simple visual reaction time tasks \[Johns Drowsiness Score (JDS) and Psychomotor Vigilance Task (PVT) lapses\] - will be lower on the SCS intervention schedule than on the traditional schedule. (major secondary endpoints: resident neurobehavioral performance and predicted driving safety)


Options:
A: Inclusion Criteria:

* Excessive sleepiness, and Epworth Sleepiness Score \> or = 8
* Apnea- Hypopnea-Index (AHI) \> or = 10/hour
* Age 18-75

Exclusion Criteria:

* Psychophysiological incapacity to perform questionnaires
* Other sleep disorders
* Psychiatric disease requiring treatment
* Previous CPAP therapy
* Previous uvulopalatopharyngoplasty
* Chronic nasal obstruction that required treatment for more than 1 month
* Cancer
* COPD, with FEV1 \< 50% predicted
* Symptomatic cardiovascular disease requiring treatment defined as congestive heart failure \> NYHA II
* Previous stroke with neurological residuum
* Cheyne-Stokes respiration
* Chronic pain syndromes, fibromyalgia
* Drug or alcohol addiction
B: Inclusion criteria:

1. Objectively confirmed obstructive sleep apnoea (at the time of original diagnosis) with an oxygen desaturation index (ODI, \>4% dips) of between 10 and 50/h and an ESS of \>10 (these thresholds will exclude subjects with borderline and very severe forms of OSA in whom there may be a disproportionate treatment effect).
2. Currently \>10/h oxygen desaturations (\>4% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP.
3. Treated with NCPAP for more than 12 months, minimum compliance 4h per night.
4. Current ESS \< 10.
5. Written informed consent.

Exclusion criteria:

1. Previous ventilatory failure (awake resting arterial oxygen saturation \<93% or arterial PCO2 \> 6kPa).
2. Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension (\>180/110mmHg).
3. Previously diagnosed with Cheyne-Stokes breathing.
4. Current professional driver.
5. Any sleep related accident.
6. Age \<20 or \>75 years at trial entry.
7. History of chronic nasal obstruction.
8. Mental or physical disability precluding informed consent or compliance with the protocol .
9. Non-feasible trial follow-up (for example, distance from follow-up centre, physical inability).
C: Inclusion Criteria:

* Current internal medicine program in the United States Continued Accreditation status with the ACGME - Program director agrees to:

  1. Randomization to one of the two study arms.
  2. Develop, and share with the study team, institutional duty hour schedules and regulatory policies/procedures that will ensure adherence to, and enforcement of, the duty hour regulations that apply to their study arm
  3. Allow access and analysis of de-identified resident duty hour adherence data/logs, call schedules, and rotation schedules to the Study Team.
  4. Participate, and encourage trainee participation at your institution, in beginning and end of year iCOMPARE surveys.

Exclusion Criteria:

* The investigators excluded 119 programs that comprise the bottom 50% in resident-to-bed ratio and the bottom 25% in patient volume related to the diagnoses by which the patient population will be selected for evaluation of safety outcomes.
* Within the 260 programs that remain, the investigators excluded the 65 in the lowest quartile of program size to ensure we can feasibly obtain sufficient trainee measurements.
* The 195 remaining programs are eligible for inclusion.
* The investigators have also excluded children and VA hospitals.
D: Inclusion Criteria:

* Must be a second or third year resident of pediatrics or a combined pediatrics program

Exclusion Criteria:

-

Answer: D