I.   Objective Sleep Study Metrics

     a. Recommended Primary Metrics:

              i.AHI

             ii.Apnea Index

            iii.ODI (4%)

            iv.%TST90: % of sleep time spent < 90% Sat

     b. Secondary Metrics (encouraged):

              i.Supine AHI

             ii.Non-Supine AHI

            iii.Central apnea % of total events

     c.Removed:

             i.O2 Sat Nadir (LSAT)

 

II.   Patient Reported Outcome Measures

     a.Primary measures (committed to use):

            i.Snoring Bother:  How bothersome is your snoring currently? (Likert Scale:  0=None to               10=Severe)

           ii.ESS

          iii.Global OSA-related quality of life change

     b.Secondary measures (encouraged):

            i.FOSQ

           ii.SNORE-25

 

Permissions:
SNORE-25: Stacey Ishman, Eric Kezirian, and Ed Waver obtained permissions for use from Jay Piccirillo.

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FOSQ-10: approved from Terri Weaver for research (circulated but not to be shared online); letter of agreement needed to send and receive scoring instructions.

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Cardiovascular Outcome Measures

     a.Proposed measures (optional):

           i.Blood pressure (night of and morning after PSG)

          ii.De-escalation or change in blood pressure medication(s) or dosing

The ISSS Research Workshop considered a list of loosely defined “real life”, “actual” and “surrogate” cardiovascular outcome metrics in OSA treatment.

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ISSS 2022 Recommended Metrics for Studies on Sleep Surgery Outcomes

1. How bothersome is your snoring currently (0 = None, 10 = Severe)?

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2. Epworth Sleepiness Scale (attached)

3. Global OSA-related quality of life change:

In terms of your sleep apnea and your health,has there been any change in

your quality of life since the first time you came to Sleep Surgery Clinic?

                          

                           If better:                                                             If worse:

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Figure. Global Sleep Apnea Quality of Life Change instrument: 15-item (range ---7 to +7)
 

        4. Apnea-hypopnea index (AHI)

        5.Apnea index

        6. Oxygen desaturation index 4%

        7. Percent of total sleep time with oxygen saturation <90%

Secondary (optional):

        1. Functional Outcomes of Sleep Questionnaire – 10 (attached)

            Note: Per Dr. Terri Weaver (owner of FOSQ and FOSQ-10), this questionnaire is OK to send out to ISSS members              but should not be placed into the public domain, whether online or in any publication. If any members would like                to use the FOSQ-10, they should complete the attached Letter of Agreement and return to Dr. Weaver                                at penntw@yahoo.com. She will then send the scoring instructions for the FOSQ-10.

        2. SNORE-25 (attached, including scoring instructions)

            Note: Jay Piccirillo (owner of SNORE-25) has authorized sharing the instrument and scoring instructions with ISSS                members.

        3. Supine AHI

        4. Non-supine AHI

        5. Central apnea % of total events

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Philadelphia 2022 ISSS: Drug Induced Sleep Endoscopy Research Group Meeting

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ISSS Research Group participants recognize the benefit of drug induced sleep endoscopy (DISE) in the evaluation of sleep apnea. There is strong group interest in standardization of DISE, utility in patient selection, and prediction of surgical outcomes.  Summaries of each presentation and discussion can be found below.

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Pediatric Drug Induced Sleep Endoscopy (Dr. Erin M. Kirkham, University of Michigan)

Summary: There is no consensus or standardization in pediatrics- more research is needed

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Pharyngeal Opening Pressure (Dr. Raj C. Dedhia, University of Pennsylvania)

Summary: DISE with administration of PAP (DISE-PAP) combines endoscopic evaluation with physiologic measures of upper airway collapsibility. Pharyngeal opening pressure (PhOP) is the pressure at which inspiratory flow limitation is completely abolished and is a novel, objective measure of global airway collapsibility. There was consensus that there is a need for a measure to help predict surgical outcomes and that this should be a focus of future research on physiologic measures of airway collapse, such as PhOP

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Drug Induced Sleep Endoscopy and Surgical Outcomes (Dr. Olivier M. Vanderveken, Antwerp University Hospital)

Summary: DISE is viewed as a standard of care for decision making for the surgical treatment of OSA. National reimbursement and some guidelines require DISE for surgical treatment. How can we increase the evidence level for DISE in surgical decision making?

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Cardiovascular    : The ISSS Research Workshop considered a list of loosely defined “real life”, “actual” and “surrogate” cardiovascular outcome metrics in OSA treatment. A detailed sample of this list is shown in FIGURE X.

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POTENTIAL CARDIOVASCULAR OUTCOME MEASURES in OSA/and BEFORE/AFTER OSA TREATMENT

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FIGURE X

Workshop participants considered components of the list as collectable metrics. Whilst it was recognized smaller surgical studies have shown 24 hour blood pressure improvements (Lateral pharyngoplasty reduces nocturnal blood pressure in patients with obstructive sleep apnea Laryngoscope, 124:311–316, 2014 De Paula Soares et al) or trends to change (SAMS trial), and others have demonstrated surgery reduces single measures in blood pressure (Alternations of Blood Pressure Before and After OSA Surgery Otolaryngology-Head & Neck surgery, Vol 163, Issue 4, 2020,Redefining the Timing of Surgery for Obstructive Sleep Apnea in Anatomically Favorable Patients Laryngoscope, 124:S1–S9, 2014 Rotenberg et al,Blood pressure after Modified Uvulopalatopharyngoplasty: results from the SKUP3 randomized controlled trial. Sleep Medicine Vol 34 June 2017, p156-161, Fehrm et al), the workshop committee felt it best that such studies were performed as single or multi-center trials, rather than ISSS database collection analyses.

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In terms of “real life” metrics of cardiovascular outcomes following OSA surgery, the workshop recognized excellent large database study publications (for example Ibrahim et al JAMAOtolaryngolHeadNeckSurg.doi:10.1001/jamaoto.2020.5179) and single center long term observational studies (Peker Y et al doi:10.1164/rccm.2105124). It was deemed appropriate that such studies are confined to larger database sets and interested institutions, rather than ISSS member collectives.

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“Actual” metrics, such as the degree of carotid intimal thickening, could also be utilized in units with the investment, interest and ability to study such markers. Future pathways may also involve select sites evaluating hypoxic burden (Azarbarzin et al European Heart Journal 2019 40 1149-1157).

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Despite the above, interested members were encouraged to collect “night of and morning after” in laboratory polysomnography blood pressure readings, but recent direction towards level II studies may restrict the volume of such collection. It was also recommended that “de-escalation” of blood pressure medication/dosing could be collected by a subgroup of OSA surgical centers, based on prior similar CPAP studies (Dernaika TA et al  Effects of nocturnal continuous positive airway pressure therapy in patients with resistant hypertension and obstructive sleep apnea. J Clin Sleep Med 2009;5(2):103–107).

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TABLE OUTLINING ISSS HYPOGLOSSAL NERVE STIMULATION RESEARCH COMMITTEE PERSPECTIVES/

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