Adults with obstruction at any or all of the four levels of interest (velopharynx, oropharynx, tongue base, epiglottis) will represent the experimental group.

Children with obstruction at any or all of the four levels of interest (velopharynx, oropharynx, tongue base, epiglottis) will represent the experimental group.

Adult without any obstruction at four levels of interest (velopharynx, oropharynx, tongue base, epiglottis) will represent a control.

Children exam will be done for all the participants. Subject without obstruction represent a control.

Obstructive Sleep Apnea

DISE involves administering anesthetic to a patient to simulate a sleep state, and then visualizing the upper airway using transnasal flexible endoscopy. Sites of obstruction at key locations including the adenoids, soft palate, lateral oropharynx, tongue base, and epiglottis can be identified.

Drug-induced sleep endoscopy (DISE)

After the necessary clinical information has been obtained (if obstruction is occurring at those levels and, if so, to what degree), a flexible high-resolution manometry (HRM) catheter will be passes through the contralateral nostril to record pressure along the length of the pharynx at those same sites.

High-resolution manometry (HRM):

University of Wisconsin

Use of High-resolution Manometry to Detect Upper Airway Obstruction During Sleep

Baseline pressure at different levels of obstruction in OSA participants will be measured by HRM. The aim is to determine if HRM can identify obstruction at the velopharynx, oropharynx, tongue base, and epiglottis as seen on DISE. obstruction at each site will be identified on DISE. Subject data will be divided into three groups for each site based on results from the DISE exam, which are currently used clinically: no obstruction (<50% obstructed), partial obstruction (50-75% obstruction), or complete obstruction (>75% obstruction). Investigator will be checking if values differ across the three categories of obstruction.

Maximum pressure at different levels of obstruction in OSA participants will be measured by HRM. The aim is to determine if HRM can identify obstruction at the velopharynx, oropharynx, tongue base, and epiglottis as seen on DISE. obstruction at each site will be identified on DISE. Subject data will be divided into three groups for each site based on results from the DISE exam, which are currently used clinically: no obstruction (<50% obstructed), partial obstruction (50-75% obstruction), or complete obstruction (>75% obstruction). Investigator will be checking if values differ across the three categories of obstruction.

Duration of pressure at different regions of obstruction in OSA participants will be measured by HRM. The aim is to determine if HRM can identify obstruction at the velopharynx, oropharynx, tongue base, and epiglottis as seen on DISE. obstruction at each site will be identified on DISE. Subject data will be divided into three groups for each site based on results from the DISE exam, which are currently used clinically: no obstruction (<50% obstructed), partial obstruction (50-75% obstruction), or complete obstruction (>75% obstruction). Investigator will be checking if values differ across the three categories of obstruction.

Pressure integral at different regions of obstruction in OSA participants will be measured by HRM. The aim is to determine if HRM can identify obstruction at the velopharynx, oropharynx, tongue base, and epiglottis as seen on DISE. obstruction at each site will be identified on DISE. Subject data will be divided into three groups for each site based on results from the DISE exam, which are currently used clinically: no obstruction (<50% obstructed), partial obstruction (50-75% obstruction), or complete obstruction (>75% obstruction). Investigator will be checking if values differ across the three categories of obstruction.

Number of participants identified with upper airway obstruction during sleep will be a parameter to compare the efficacy of HRM and to evaluate if HRM can compliment DISE for diagnosing the level of obstruction. Obstruction can be at the velopharynx, oropharynx, tongue base, and epiglottis

To determine the relationship between manometric variables and standard assessment used to evaluate OSA, apnea-hypopnea index (AHI) will be obtained from polysomnography.
AHI is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. Combining AHI and oxygen desaturation gives an overall sleep apnea severity score that evaluates both the number of sleep disruptions and the degree of oxygen desaturation (low oxygen level in the blood).
The AHI values for adults are categorized as:
Normal: AHI<5 Mild sleep apnea: 5≤AHI<15 Moderate sleep apnea: 15≤AHI<30 Severe sleep apnea: AHI≥30 For children, because of their different physiology, an AHI in excess of 1 is considered abnormal. Pediatric patients presenting with AHI of 2 or greater will often be referred for treatment.

To determine the relationship between manometric variables and standard assessment used to evaluate OSA, Pediatric Sleep Questionnaire score will be obtained.
This scale contains 22 symptom items that ask about snoring frequency, loud snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, inattentive or hyperactive behavior, and other pediatric OSA features. If eight or more statements are answered "yes", child is referred for sleep evaluation. Higher score correlates to more severe OSA.

To determine the relationship between manometric variables and standard assessment used to evaluate OSA, Epworth Sleepiness Scale score will be obtained.
The Epworth Sleepiness Scale is widely used in the field of sleep medicine as a subjective measure of a patient's sleepiness. The test is a list of eight situations in which participants rate their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. When they finish the test, the values are added up. The total score is based on a scale of 0 to 24. The scale estimates whether the participants are experiencing excessive sleepiness that possibly requires medical attention. Scores range from 0 to 24, having scores above 9 implicate that the person is considerably sleepy to seek medical attention.

To determine the relationship between manometric variables and standard assessment used to evaluate OSA, STOP-BANG Sleep Apnea Questionnaire score will be obtained.
The snoring, tiredness, observed apnea, high BP (STOP) and snoring, tiredness, observed apnea, high BP-BMI, age, neck circumference and gender (STOP-Bang) questionnaire consists of 8 yes/no questions.
For general population Low risk of OSA: Yes to 0-2 questions Intermediate risk of OSA: Yes to 3-4 questions High risk of OSA: Yes to 5-8 questions or Yes to 2 or more of 4 STOP questions + male gender or Yes to 2 or more of 4 STOP questions + BMI > 35 kg/m2 or Yes to 2 or more of 4 STOP questions + neck circumference (17"/43cm in male, 16"/41cm in female)

to determine if manometric variables can predict which subjects benefit from surgical interventions (performed as part of standard clinical care) based on changes in postoperative obstructive sleep apnea assessments.

In this study, "improvement" in OSA symptoms will be defined as at least a 50% change in AHI or questionnaire score. Logistic regression analyses will be performed to determine if there is a difference in the aforementioned manometric parameters between patients who improve and do not improve for interventions at a given level (velopharynx, oropharynx, tongue base, epiglottis).

Data will only be analyzed from spontaneous swallows that occur while the subjects are under an anesthesia-induced sleep state. Thus, all spontaneous swallows will only be saliva swallows (i.e., no food or liquid will be delivered to the subjects, as they will be under anesthesia and any bolus swallows would not be safe).
Manometric data will be collected during spontaneous swallows (both adults and children) and pressure variables normally calculated for awake adult swallowing will be extracted from the velopharynx, tongue base, hypopharynx, and upper esophageal sphincter regions. Data for this aim will only be analyzed descriptively

University of Wisconsin, Madison

This blend contains Ginko at 120 mg/day and Cistanche at 300 mg/day

This blend contains Ginko at 180 mg/day and Cistanche at 450 mg/day

Mental Fatigue

Fatigue

Chronic Fatigue Syndrome

Experimental: Nutrilite® Low dose

Experimental: Nutrilite® High dose

Placebo Comparator: Placebo

Effect of Ginko and Cistanche Against Fatigue Symptoms

A 60-Day Clinical Study to Evaluate Nutrilite Ginko Biloba Cistanche Tablets in Relieving the Symptoms of Chronic Fatigue Syndromes Compared to Negative Control

enuresis/главоболие

Use of High-resolution Manometry to Detect Upper Airway Obstruction During Sleep

Effect of Ginko and Cistanche Against Fatigue Symptoms

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