Ultrasound Against Obstructive Sleep Apnea
Ultrasound Against Obstructive Sleep Apnea
To investigate the accuracy of neck ultrasound in identifying and discriminating the severity
 of obstructive sleep apnea (OSA).

 Primary objective: To test the hypothesis that ultrasound can be used as a reliable tool for
 identifying the anatomic characteristics and dynamic changes of pharyngeal airspace in
 patients with OSA.

 Secondary objective: Investigate if ultrasound can be used to discriminate OSA severity.

 The investigators will compare these results to the results from polysomnography study.
Investigators are conducting a prospective randomized control trial. Two-thirds of the
 participants will be randomly selected as the model-development group while the remaining
 one-third will serve as the validation group. The allocation will be based on a
 computer-generated random assignment. Ultrasonography and polysomnography operators will be
 blinded to other results.

 Anthropometric Measurements:

 Demographic data, including age, gender, weight (kilograms), body height (centimeters) and
 neck circumference (NC), will be recorded. Weight and height will be recorded with the
 patients wearing light clothes, but no shoes. Body mass index (BMI) will be then calculated
 as weight (kg) divided by height squared (mt2). NC will be measured (in cm) with a flexible
 tape at the level of the cricothyroid membrane after a gentle expiration by the subject while
 standing upright. History of hypertension, diabetes, hyperlipidemia or any other
 cardiovascular diseases will be recorded according to medical records or statements by the
 patients. All participants will be asked to complete the Epworth Sleepiness Scale (ESS), a
 subjective self-reported measure of excessive daytime sleepiness, within the same session
 before the ultrasound examination.

 Polysomnography :

 Full-night polysomnography (PSG) will be performed in the sleep laboratory according to
 protocol of sleep medicine department after US assessment. Apnea will be defined as the
 absence of airflow ≥10 sec and hypopnea will be defined as >50% decrease in airflow ≥10 sec
 associated with reduced arterial oxygen saturation by 4%, or an arousal. These two parameters
 are collectively defined as apnea-hypopnea index (AHI). An arousal will be recorded if there
 is a 3 second or longer abrupt shift in electroencephalogram frequency to alpha or theta or
 above 16 Hertz, following at least 10 seconds of sleep, and, if arising in rapid eye movement
 sleep, there should be a rise in electromyographic tone. An independent technician blinded to
 the US results will analyze the sleep studies.

 Episodes of AHI per hour will be used to diagnose and grade the severity of OSA:

 Non-OSA : < 5/hr mild OSA : 5- 14/hr moderate OSA:15-29/hr and severe OSA : ≥30/hr.

 Ultrasonography:

 The US will be done by an independent operator. All the measurements will be made by the same
 operator, who is experienced in US scanning and will be blinded to the polysomnographic data.

 Lateral Pharyngeal Wall (LPW) scanning

 1. Participants will lay supine on the examination couch. The neck of the participant will
 be slightly extended, with the infraorbital meatal baseline (the line joining
 infraorbital margin and ear tragus) perpendicular to the scanning table. A 35° soft pad
 will be placed under the neck.

 2. C5-2 or C7-5 Mega hertz curvilinear transducer will be used. The oblique coronal plane
 of the parapharyngeal space will be scanned with the transducer longitudinally placed on
 the lateral side of the neck, just underneath the lateral border of the occipital bone.

 3. The long axis of the ipsilateral internal carotid artery will be identified with color
 application.

 4. The distance between the internal carotid artery and the echogenic surface of pharynx
 will be used to measure the LPW thickness in an oblique coronal plane.

 5. All the measurements will be recorded on frozen images when the lateral wall of the
 pharynx moves farthest away from the transducer (presumably the airway will decrease to
 its smallest caliber).

 6. The maximum thickness of LPW on both sides will be measured 3 times on 3 separate
 images, and the mean value will be obtained for analysis. Values on both sides of the
 neck will be summed to determine the total LPW thickness measured by ultrasound.

 Submental scanning Before the measurement of dynamic changes, participants will be given time
 to practice the maneuvers under instruction. Forced inspiration will be desired to approach
 the inspiratory reserve volume by maximal effort of inspiration within 3 sec. Mullers
 maneuver (reverse valsalva) will be performed by an attempt at vigorous inhalation with the
 mouth and nose closed. To localize measurement, two strategies will be applied. First, no
 shoulder and head movement will be allowed during the maneuver. We will measure the airspace
 3 times in every participant based on the same level of US-structure composed of tongue,
 hypoglossal muscle and geniohyoid muscle and the final recorded value will be mean of the
 three values.

 1. Position and plane of scanning - Investigators will place awake the participant in
 supine position with infraorbital meatal baseline perpendicular to the scanning table,
 similar to the position used for lateral pharyngeal wall measurement.

 2. Locate the pharynx through HM plane: We will scan from hyoid bone to external auditory
 meatus (HM plane), at level of oropharynx. The transverse diameter of pharynx will be
 determined by outer margin of air-column on ultrasound.

 3. Measurement of dynamic change of airspace: The probe will be tilted upward and downward
 gradually to locate Retropalatal (RP) and Retroglossal (RG) in pharynx, defined as air
 column at the highest plane near the uvula before it was obscured by soft palate & at
 the plane just above hyoid bone, respectively. The transverse diameters of RP and RG are
 determined by outer margin of air-column, where they were measured at Muller's maneuver,
 inspiration and expiration.

 4. The midline sagittal plane of the tongue base was scanned with the transducer placed on
 the submental skin of the neck, between the hyoid bone and the symphysis of the
 mandible. The operator may tilt the transducer slightly aside to search the hyperechoic
 raphe of the tongue, which is the landmark of the midline septum of the tongue. The
 participant will be first instructed to remain still and silent during the measurements
 and to breathe normally and avoid tongue movement, swallowing or talking. The maximum
 distance between the submental skin and the dorsal surface of the tongue base, tongue
 base thickness (TBT eupneic), and subcutaneous fat thickness (SFT - eupneic), were
 recorded and measured on frozen ultrasound images at the end of expiration during
 eupneic breathing and during Muller's maneuver.

 The TBT and SFT will be recorded and measured on frozen ultrasound images on performance of
 the MM with the tongue base positioned farthest away from the transducer (i.e. with the
 pharyngeal airway presumably decreased to its smallest caliber). The maximum TBT and SFT on
 the Muller's Maneuver (MM) were measured three times on three separate images, and the mean
 values, TBT (MM) and SFT (MM), will be obtained for analysis. The difference in TBT, TBT
 (difference), on eupneic breathing and the MM was defined as TBT (MM) - TBT (eupneic). The
 difference in SFT, SFT (difference), on eupneic breathing and the MM will be defined as SFT
 (MM) - SFT (eupneic). TBT (difference) and SFT (difference) will be computed for each
 participant for further analysis.

 Reliability Study - To guard against US operator bias fifteen participants will be invited to
 take part in the reliability study of ultra-sonographic measurement. Participants will be
 scanned and repositioned by 2 operators independently on the same day for the assessment of
 inter-operator reliability, and each operator will be blinded to the examination results of
 the other operator. The participants will be then scanned by the main US operator again 2 to
 3 weeks later to determine intra operator reliability. Participants will be provided
 appropriate fare for their travel.
Inclusion Criteria:

 -  All patients aged ≥18 years-old and who are arranged to receive polysomnography for
 suspected OSA, as per STOP BANG questionnaire, will be eligible for the study

 Exclusion Criteria:

 -  Refusal to participate

 -  Inability to perform the maneuvers

 -  Presence of congestive heart failure

 -  Presence of chronic pulmonary disease demonstrated on pulmonary function testing

 -  Active neurologic event

 -  Active infection or surgery four weeks prior to screening

 -  Active inflammation in head and neck region

 -  Burns, trauma, radiotherapy involving head and neck region

 -  Other diagnosis of sleep disorders

 -  Ascites, benign or malignant abdominal mass and

 -  Pregnancy

 -  Craniofacial abnormalities

 -  Presence of severe nasal obstruction

 -  Oral cavity, Oropharyngeal or laryngeal masses

 -  Cervical rigidity with limited neck flexion and head extension

 -  No previous diagnosis of OSA or treatment instituted for OSA

 -  Any patients whose PSG reports had a total sleep time of less than two hours or had no
 rapid eye movement sleep will be excluded from the study.