Obstructive Sleep Apnea in Pregnancy
Condition: Sleep Apnea, Obstructive; Pregnancy; Obesity, Morbid
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Obesity, Morbid
Study type: Observational

Summary: 
      Obstructive sleep apnea (OSA) is a risk factor for complications during pregnancy and current
      screening tools for OSA have not been shown to be reliable in pregnant women. The primary aim
      of this study is to develop a valid screening tool to identify at-risk pregnant women, so
      that they can be further evaluated and treated. Women with OSA may also be at risk for
      respiratory complications related to opiate administration for post-cesarean delivery pain. A
      secondary aim of this study is to evaluate post-operative minute ventilation in women who
      undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring.
    

Detailed description: 
      Following recruitment and informed consent, subjects will complete 3 screening questionnaires
      for OSA: the Berlin and STOP-BANG questionnaires, and the Epworth Sleepiness Scale. They will
      also undergo a physical exam by one of the study investigators including examination of the
      neck and upper airway to assess neck circumference, retrognathia, thyromental space, tongue
      scalloping, MMS, modified MMS, tonsil size and lateral pharyngeal wall narrowing.

      Subjects will all receive ApneaLink™ Air (ResMed, Poway, CA), a FDA-approved, non-invasive,
      portable, home polysomnography device, and instructions for using the device during one night
      of sleep. They will be given contact information if they have questions regarding use of the
      device. Subjects will receive a prepaid FedEx envelope to return the device. They will
      receive a parking voucher worth up to a maximum of $7 during this appointment. Subjects will
      be compensated ($50 check by mail) once the device is received. A follow-up phone call will
      be made by the PI to inform the subject of the results of the home polysomnography study.
      Subjects who screen positive (AHI > 5) by home polysomnography will be referred to Duke Sleep
      Medicine for further evaluation. Pregnancy outcomes will be followed for all subjects.

      Enrolled subjects who go on to have a cesarean delivery will be studied using ExSpiron
      (Respiratory Motion, Inc., Waltham, MA), a FDA-approved, non-invasive respiratory volume
      monitor for 24 hours. The monitor has three adhesive pads that attach to the chest wall and a
      cord that attaches to the monitoring device, similar to an electrocardiogram. The monitor can
      be detached and the study suspended when patients ambulate to the restroom, and should not
      interfere with breastfeeding. The monitor will be connected to the patient in the
      pre-operative holding area, and the monitor will be calibrated with baseline spirometry
      measurements using a Wright spirometer over one minute. The subject will wear the device for
      the duration of the surgery, in the recovery room, and for 24 following surgery. The
      non-invasive respiratory volume monitor will be collected by study personnel at the
      conclusion of the 24 hours, and no data collected from the monitor will be used for clinical
      decision-making. Standard of care will be followed for the antepartum, intrapartum and
      postpartum management of those patients. Patients will continue to be monitored using the
      investigators' standard protocol for patients who have received neuraxial morphine which
      consists of continuous monitoring for 2 hours, followed by monitoring every 2 hours for 24
      hours of the following: vital signs, oxygen saturation, respiratory rate, pain score and
      sedation score. The investigators also have nursing standing orders for naloxone
      administration for respiratory rate < 8 breaths/min or Richmond Agitation Sedation Scale
      (RASS) ≤ -3, together with immediate notification of medical staff, as well an order to
      notify medical staff for oxygen saturation < 90% or RASS < -2.
    

Intervention name(s): ApneaLink Air; Berlin Quesionnaire; Epworth Sleepiness Scale; STOP-BANG questionnaire; Physical exam
Intervention type(s): Device; Behavioral; Behavioral; Behavioral; Other
Intervention description(s): Overnight, home polysomnography device; OSA screening questionnaire; OSA screening questionnaire; OSA screening questionnaire; Physical exam of neck, mouth and upper airway
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women, ages 18-50 years old, BMI > or equal to 40 kg/m2, without a prior diagnosis
        of obstructive sleep apnea or chronic narcotic use.
      
Biospecimen description: 
      Serum
    
Keywords: Sleep Apnea, Obstructive; Pregnancy; Obesity, Morbid; Complications, pregnancy