Toronto Western Hospital (TWH)-University Health Network (UHN)
Toronto, Ontario, M5T 2S8, Canada
Location contact
Abdel Basit Al Hawwari, MSN, RN
CONTACT
4166035800 ext. 3959
Mandeep Singh, MBBS, FRCPC
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06776237
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.
Trial opening soon.
Get Notified18 year and older
Female
Observational
Toronto, Ontario, M5T 2S8, Canada
Abdel Basit Al Hawwari, MSN, RN
CONTACT
4166035800 ext. 3959
Mandeep Singh, MBBS, FRCPC
PRINCIPAL_INVESTIGATOR
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,
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
High risk of OSA will be defined as outlined by Facco et al. and recommended by recently updated guidelines (i.e., score ≥ 75) (8).
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.
Time frame: One Day
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.
Time frame: One Day
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
Contact information is provided by the study sponsor or research team.
University Health Network, Toronto
Other
Point of Care Ultrasound (PoCUS) as a Tool to Evaluate Patients at High Risk of Obstructive Sleep Apnea in the Obstetric Population
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07730879
Apnea, Cardiovascular Diseases
Braga, Portugal
View Trial DetailsNCT07720219
Apnea, Dyssomnias
View Trial DetailsNCT07711678
Apnea, Dyssomnias
Beijing, Beijing Municipality, China
View Trial DetailsNCT07693101
Apnea, Dyssomnias
View Trial Details