Clinical trial NCT04139499: Use of High-resolution Manometry to Detect Upper Airway Obstruction During Sleep
Official title: Use of High-resolution Manometry to Detect Upper Airway Obstruction During Sleep
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Keywords: sleep apnea
Continuous positive airway pressure (CPAP)
Sleep manometry
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 172
Sex: ALL
Minimum age (years): 5
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Majority of subjects will be those children and adults who will be undergoing DISE as part of their standard clinical care.

However, it is desirable to have cleaner controls without obstruction at any level to confirm that the visual absence of obstruction also represents a manometrically normal respiration. Thus, subjects without symptoms of obstructive sleep apnea who are undergoing a surgical procedure will be recruited. Simultaneous performance of DISE (to confirm no obstruction) and HRM in such subjects would take about 5 minutes. Further, the time required is within the variability typically expected at an academic center where trainees may participate in cases.

Brief summary: Obstructive sleep apnea (OSA) is a major public health issue in both children and adults, present in 1-5% of children and 10-30% of adults. It is characterized by repeated episodes of airway obstruction during sleep, leading to brain arousal, sympathetic activation, oxygen desaturation, sleep fragmentation, and non-restorative sleep. Patients report daytime tiredness, insomnia, and morning headaches. Children with OSA experience daytime somnolence, difficulties at school, behavioral problems, enuresis, and reduced quality of life. If left untreated, OSA can lead to numerous complications including hypertension, cardiovascular disease, stroke, and insulin resistance. Sleep partners are also affected, with patients viewing their disorder as a burden and sleeping in separate rooms. Further, disease prevalence is increasing as obesity increases.

Continuous positive airway pressure (CPAP) is the current gold standard treatment for OSA. If used effectively and consistently, it can improve patient symptoms. However, adherence is generally poor, with patients experiencing physical discomfort, chest discomfort, and dry mouth. For those patients that cannot tolerate CPAP, surgical intervention is an option. In children, this typically starts with adenotonsillectomy. However, 20-75% of children will have persistent symptoms after adenotonsillectomy. In adults, anatomic factors including tonsil hypertrophy and redundant pharyngeal tissue can contribute to upper airway obstruction and may also necessitate higher pressures for effective CPAP treatment. Even if surgical intervention does not cure the OSA, it may make CPAP more tolerable and improve CPAP adherence.

Sleep-related airway obstruction is a complex phenomenon potentially involving multiple anatomic levels. For patients with persistent symptoms despite initial therapy or intolerance to CPAP, further evaluation of the upper airway is clinically valuable. Polysomnography (PSG) is the gold standard for diagnosing OSA, but it does not provide information on the location(s) of upper airway obstruction. Knowledge of the precise sites of obstruction is critical to planning effective sleep surgery. Currently, this is accomplished with drug-induced sleep endoscopy (DISE). DISE was originally proposed in 1991 and 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.

Though DISE offers valuable clinical information, it has notable limitations. First, it cannot evaluate the entire upper airway simultaneously, as any obstruction occurring superiorly precludes visualization of any obstruction occurring more inferiorly. Second, interpretation of DISE is subjective and there is no universally accepted system for analysis. Rating systems are qualitative, using grades such as complete, partial, or no obstruction as opposed to quantitative measurements.

The optimal sleep assessment would be quantitative, reliable, and provide information on the entire upper airway simultaneously. A potential alternative to DISE which could meet these criteria is sleep manometry. Measurement of upper airway pressures captures the effects of obstruction along the entire upper airway, from the nasopharynx to larynx. Prior studies have attempted to employ manometry, but have been limited primarily by inadequate equipment and suboptimal methods of data analysis. Woodson et al. used a solid-state manometer with diameter of 2.3 mm and 5 sensors to detect palatal obstruction and tongue base obstruction in patients with OSA. They also used the same approach to detect persistent tongue base obstruction following uvulopalatopharyngoplasty. While these studies help demonstrate that manometry can be a useful adjunct to OSA assessment, they are severely limited both by the type of manometer used as well as the lack of a clear, detailed description of the method of data analysis.

High-resolution manometry (HRM) uses pressure censors spaced 1 cm apart to allow for pressure measurement along the entire upper airway. The investigators have previously applied HRM to assessment of swallow physiology. Sophisticated methods of automated data analysis have been developed that have been shown to be reliable for both expert and novice users . Further, pattern recognition techniques have been applied to identify dysphagia and specific swallowing abnormalities. Application of this technology and modification of existing data analysis platforms will allow for a quantitative, reliable, and comprehensive assessment of upper airway obstruction during sleep in both children and adults, with potential for development of algorithms to predict effects of targeted surgical therapy at all levels of the upper airway.


Eligibility criteria: Inclusion Criteria:

ADULTS

* Age 18-90
* Any participant undergoing sleep endoscopy as part of standard clinical care would be eligible. This entails physician concern for sleep-disordered breathing and corresponding questionnaire and/or polysomnogram results supporting a diagnosis of obstructive sleep apnea.
* Participants without apnea are eligible, provided they are undergoing tonsillectomy or bronchoscopy for either chronic tonsillitis or airway assessment without concern for history of sleep apnea.
* Women with childbearing potential will not be excluded, as the proposed experiment would have no potential ramifications on childbearing potential.

CHILDREN

* Age 5-17
* Any patients undergoing sleep endoscopy as part of standard clinical care would be eligible.
* Participants undergoing either tonsillectomy for chronic tonsillitis or bronchoscopy for airway assessment.
* Women with childbearing potential will not be excluded, as the proposed experiment would have no potential ramifications on childbearing potential.

Exclusion Criteria:

* Participant desire to avoid added anesthesia time.
* Inability to safely tolerate the added anesthesia time (about 5-10 minutes) for the experiment (as judged by either otolaryngologist or anesthesiologist).
* Pregnant women
* Vulnerable groups (i.e., prisoners, individuals lacking consent capacity, individuals unable to read the consent form).

Primary outcomes:
measure: Baseline pressure at different levels of obstruction in OSA participants as measured by HRM
timeFrame: Up to 24 hour
measure: Maximum pressure at different levels of obstruction in OSA participants as measured by HRM
timeFrame: Up to 24 hour
measure: Duration of pressure elevation at different levels of obstruction in OSA participants as measured by HRM
timeFrame: Up to 24 hour
measure: Pressure integral at different levels of obstruction in OSA participants as measured by HRM
timeFrame: Up to 24 hour
measure: Number of participants identified with upper airway obstruction during sleep using DISE vs HRM
timeFrame: Up to 24 hour
measure: Apnea-hypopnea index (AHI) as obtained from polysomnography
timeFrame: Up to 24 hour
measure: Pediatric Sleep Questionnaire score as an indicator of OSA severity
timeFrame: Up to 24 hour
measure: Epworth Sleepiness Scale score as an indicator of OSA severity
timeFrame: Up to 24 hour
measure: To determine the relationship between manometric variables and STOP-BANG Sleep Apnea Questionnaire score
timeFrame: Up to 24 hour
measure: Efficacy of manometric variables to predict which subjects benefit from surgical interventions for OSA
timeFrame: 2 years
measure: Correlation between the outcome of surgery and manometric variables as assessed by the number of participants with improved Apnea-hypopnea index (AHI) after surgery
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
measure: Pharyngeal pressures from spontaneous saliva swallows occurring during the DISE exam in pediatric and adult subjects.
timeFrame: 2 years
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Timothy M Mcculloch, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: