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| Name | Class |
|---|---|
| MOUNT SINAI HOSPITAL | OTHER |
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Pregnant women with gestational age more than 20 weeks are at risk of developing Obstructive Sleep Apnea (OSA). OSA is a common underdiagnosed comorbid condition in pregnant women associated with adverse maternal and fetal outcomes. It is a severe form of sleep-disordered breathing (SDB), featured with repeated episodes of airflow reduction or cessation during sleep. It exists in different severity among pregnant women and maybe worsen over the course of the pregnancy. If OSA remains untreated, it can complicate the pregnancy by developing heart failure, gestational diabetes, pre-eclampsia, eclampsia, and hypertension. To determine the OSA during pregnancy has become an important issue to reduce the morbidity related to it. Currently, Polysomnography (PSG) remains the gold standard for diagnosing OSA, but scheduling and logistics remain significant impediments to accessibility for pregnant women. Home sleep apnea tests (HST) is a promising alternative but are expensive and not widely available. Point of care ultrasonography (PoCUS) is being increasingly used across specialties. Our preliminary data support the feasibility of PoCUS in the preoperative setting and increasing the diagnostic accuracy and the specificity for moderate to severe OSA (AHI >15 events per h) when combined with the STOP-Bang questionnaire (cut-off >5). Given that HST shows high levels of agreement with PSG for the diagnosis of OSA and are significantly less burdensome than PSG, investigators will evaluate the PoCUS airway examination against the HST for the diagnosis of OSA in pregnant women at high risk of OSA.
This project is to define the range of mouth and tongue dimensions and to visualize airway structures by using ultrasound. Given that Home sleep apnea tests (HST) shows high levels of accuracy for the diagnosis of Obstructive sleep apnea (OSA), investigators hypothesize that the Point of care ultrasonography (PoCUS) airway examination against the HST for the diagnosis of OSA in pregnant women at the high-risk can,
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PoCUS | Diagnostic Test | Participants after getting recruited will be asked for an ultrasonography of the neck. It will take around 30 minutes. At home, participants will be asked to wear a portable sleep study device overnight, to perform home sleep study. Although these devices are noninvasive and safe, they are not routinely used as a standard of care in the pregnant patient population. |
| Measure | Description | Time Frame |
|---|---|---|
| Areas Under the Curve (AUC) | The primary outcome will be the difference in Areas Under the Curve (AUC) for each US parameter compared to the AUC of the HST obtained using the Receiver Operating Characteristic (ROC) curves for moderate to severe OSA defined as AHI > 15. | One Day |
| Measure | Description | Time Frame |
|---|---|---|
| The inter-rater reliability for measuring each one of the airway parameters | i) The inter-rater reliability for measuring each one of the airway parameters ii) The association between each US parameter and OSA severity level (none/mild/moderate/severe) iii) The association between each US parameter and OSA diagnosis derived from PSG | One Day |
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- Inclusion criteria
High risk of OSA will be defined as outlined by Facco et al. and recommended by recently updated guidelines (i.e., score ≥ 75) (8).
- Exclusion criteria i) past history of oral, head or neck surgery (e.g., corrective surgery for OSA) ii) active head and neck disease (e.g., cancer, infection, radiotherapy etc.) iii) inability to perform HST per instruction iv) patients with diagnosed OSA on CPAP therapy
Pregnant women ≥ 18 years of age
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Investigators aim to recruit 100 pregnant women ≥ 18 years of age at > 20 weeks of gestation, ASA physical status I - IV, with untreated recently diagnosed (within the previous 12 months) OSA or at high risk of OSA
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdel Basit Al Hawwari | Contact | 4166035800 | 3959 | abdelbasit.alhawwari@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Mandeep Singh, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hospital (TWH)-University Health Network (UHN) | Toronto | Ontario | M5T 2S8 | Canada |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |