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`[The Clinical Respiratory Journal
`
`Communication
`
`Setting up an ambulatory sleep research unit
`
`Eybér Bjornssonl'Z and Gunnar Guémundssonl'2
`1 Department of Allergy, Respiratory Medicine and Sleep. LandspitaIi—University Hospital, Reykjavik, Iceland
`2 Laeknasetrid, Mjodd, Reykjavik, Iceland
`
`Introduction
`
`Obstructive sleep apnoea syndrome (OSAS) has been
`described as a public health problem comparable to
`smoking in its effects upon society. Being a treatable
`illness (1), the importance of early and accurate diag—
`nosis of OSAS should be emphasized.
`Although many OSAS patients are seen by doctors on
`a regular basis (2), the syndrome is still largely unrec—
`ognized and undiagnosed (3). This may in part be
`caused by lack of training in sleep medicine or a general
`lack of awareness and also to the fact that the symptoms
`are nonspecific and have other possible causes.
`Patients are predominantly referred to a sleep clinic
`because they complain of excessive daytime sleepiness
`(EDS) or their partner complains about the noise of
`their snoring or expresses concern about witnessed
`apnoeas. Snoring is very common in the general popu—
`lation; 35—45% of men and 15%—28% of women
`report habitual snoring (4). EDS,
`like snoring,
`is
`common and a poor discriminator of the patient with
`OSAS. Of the general population without OSAS, 30%—
`50% report moderate to severe sleepiness (5).
`Consequently, clinical assessment alone is not suffi—
`cient
`to make the diagnosis of OSAS. Even sleep
`experts have been reported to be wrong in 50% of cases
`
`when making the diagnosis on history and examina—
`tion alone (6). Therefore, an objective measurement is
`always needed.
`Full polysomnography (PSG), while traditionally
`regarded as the gold standard for the diagnosis of
`OSAS, is time—consuming and expensive. Limited sleep
`studies quantify obstructive respiratory events without
`recording sleep. They are cheaper, less labour— and
`time—intensive, and technically less challenging (7)
`and, generally, there is good correlation between the
`Apnea—hypopnea index (AHI) obtained from these
`devices and PSG. These systems are usually portable
`and can be used at home, which is appreciated by the
`patients (8).
`Still, the proper way of diagnosing sleep apnoea
`remains laborious. Many common clinical problems
`can be easily diagnosed at a single clinical visit or by a
`simple laboratory test. Conversely, waiting lists at sleep
`clinics seem a global problem. Flemons et al. assessed
`the waiting list for sleep studies in five different coun—
`tries and found a variation between 2—60 months (9).
`The likelihood of increased funds to sleep clinics seems
`negligible as many hospitals in northern Europe are
`suffering cutbacks and downsizing.
`Therefore, the main issue in the management of
`sleep apnoea now is how to shorten the time to diag—
`nosis and treatment (10). We describe the set—up of a
`simple sleep research unit at a private practice facility
`and the experience during a 4—year period.
`
`Key words
`obstructive sleep — apnoea syndrome
`
`Methods
`
`Correspondence
`Eybdr BJOrnsson, MD, Department of Allergy, Respiratory
`Medicine and Sleep, Landspitali—University Hospital,
`101 Reykjavik, Iceland.
`Tel: +354 543 1000
`Fax: +354 543 6568
`
`email: eytnorbj@landspita|i.is
`
`Received: 26 June 2006
`
`Revision requested: 30 November 2006
`Accepted: 09 February 2007
`
`62
`
`Reykjavik, the capital of Iceland with surrounding
`communities, has approximately 160 000 inhabitants.
`The country’s only University Hospital is located in
`Reykjavik and many of its specialists also work part—
`time at various private practice facilities in Reykjavik.
`One such is Laeknasetrid, owned by just 70 or so phy—
`sicians of different specialties, most of whom also work
`at the University Hospital. Until the year 2000, all sleep
`studies in Iceland were conducted at the University
`Hospital. The waiting list for a sleep study at that time
`was approximately 1 year.
`
`0 ISSN 1752-6981
`The Clinical Respiratory Journal (2008)
`© 2007 The Authors. Journal compilation © 2007 Blackwell Publishing Ltd
`
`CONFIDENTIAL
`
`NOX0025829
`
`NOX EXHIBIT 2014-1
`
`IPR2016-01822
`
`NOX EXHIBIT 2014-1
`IPR2016-01822
`
`

`

`BjOrnsson and Guomundsson
`
`Ambulatory sleep research unit
`
`Table 1. Number of sleep studies in Laeknasetrid from the first
`study in 2001
`
`
`
`
` 2001 2002 2003 2004
`
`
`
`the Iceland—based
`Since its foundation in 1988,
`sleep—research company Embla (Denver, Colorado,
`USA) has worked in close collaboration with the Uni—
`versity Hospital. In 2000, the company launched its
`‘Embletta®’, a pocket—sized digital recorder with a com—
`plete system for the diagnosis of sleep—disordered
`breathing, mostly intended for home use.
`In December 2000, Laeknasetrid purchased three
`such units, along with a long—term maintenance agree—
`ment, a desktop computer and the ‘Somnologica for
`Embletta®’ software, also a Flaga product. A technician
`working at Laeknasetrid was trained to schedule mea—
`surements, deliver devices and instruct patients, and
`the following day, to obtain the devices and download
`the recordings. One of the sleep technicians at the
`hospital sleep clinic has a part—time employment at
`Laeknasetrid for the purpose of helping with the main—
`tenance of the system.
`Patients, seeking by themselves or referred by general
`physicians, are initially seen by (one of three) respira—
`tory physicians with experience in sleep medicine. If
`indicated, a sleep study is scheduled. Before the study,
`the patient is given a sleep questionnaire, including
`questions to evaluate sleep quality during the night of
`measurement. The following morning the patient
`returns the device to Laeknasetrid, along with the
`questionnaire. The fact that the patient had completed
`the study was brought to the attention of the prescrib—
`ing physician, who evaluates the recording and informs
`the patient of the results and treatment options.
`If continuous positive airway pressure (CPAP)
`treatment is indicated, the patient is referred to the
`University Hospital for mask—fitting and training.
`Follow—up is in 3 months and usually at Laeknasetrid.
`
`Results
`
`In the years 2001—2004, a mean number of 449 sleep
`recordings per year were made at Laeknasetrid. A mean
`of 372 (82.8%) sleep recordings per year were consid—
`ered both technically sound and the patient’s quality of
`sleep during that night sufficient as to make the record—
`ing a reliable indicator of sleep—related breathing
`disturbances (Table 1). Only these recordings were
`reimbursed by the State Social Security Institute
`(SSSI). In late 2003, the SSSI decided on an upper limit
`of 300 measurements per year to be reimbursed, which
`is why measurements were ceased in the last months of
`2004 when the limit for that year was reached.
`The average failure rate was 17.2%. This was
`approximately equally because of mechanical reasons
`(slackening of thoracic/abdominal belts, failure of an
`
`O ISSN 1752-6981
`The Clinical Respiratory Journal (2008)
`© 2007 The Authors. Journal compilation © 2007 Blackwell Publishing Ltd
`
`January
`February
`March
`
`April
`May
`June
`
`July
`August
`September
`October
`November
`December
`
`12
`17
`16
`
`22
`34
`68
`
`48
`50
`48
`59
`55
`42
`
`54
`42
`32
`
`43
`37
`38
`
`41
`42
`42
`45
`42
`27
`
`41
`46
`53
`
`4O
`43
`41
`
`44
`4O
`39
`46
`21
`5
`
`Total (mean: 449)
`Reimbursed (mean: 372)
`Failures (%) (mean: 17.2)
`
`471
`400
`15
`
`485
`383
`21
`
`459
`403
`12
`
`NA, not applicable.
`
`24
`44
`65
`
`40
`44
`28
`
`1 1
`25
`50
`50
`NA
`NA
`
`381
`300
`21
`
`502 probe, etc.) and patient performance in applying
`the apparatus. In these cases, the study was repeated at
`no cost to the patient. More than one repeat study was
`rarely required.
`In general, patient acceptance was good and com—
`plaints were infrequent. Patients were given a phone
`number of the corresponding physician to call in case a
`problem arose, but this was seldom used. Advanced age
`was not a hinder as patients above 80 years were
`screened without difficulties.
`
`The time that the technician at Laeknasetrid spent
`on the sleep studies was 4 h each day, 4 days/week. The
`
`Table 2. Approximate time expenditure of different
`members per measurement (min)
`
`Technician
`Physician
`Secretary
`
`staff
`
`Scheduling of
`patient/preparation of
`equipment
`Preparation/education of
`patient
`Reception and cleaning of
`equipment
`Analysis of test results
`Discussion with
`
`patient/treatment
`decision
`TIdyIng—up/storage of
`digital media
`Summary/discharge note
`Paperwork
`Total
`
`20
`
`20
`
`20
`
`0
`O
`
`10
`
`0
`O
`70
`
`0
`
`0
`
`O
`
`20
`30
`
`0
`
`10
`O
`60
`
`0
`
`0
`
`0
`
`0
`0
`
`0
`
`O
`20
`20
`
`63
`
`CONFIDENTIAL
`
`NOX0025830
`
`NOX EXHIBIT 2014-2
`
`IPR2016-01822
`
`NOX EXHIBIT 2014-2
`IPR2016-01822
`
`

`

`Ambulatory sleep research unit
`
`BJOrnsson and Guamundsson
`
`sleep technician from the University Hospital usually
`spent one afternoon/week at Laeknasetrid. The average
`amount of time spent by receptionist, technician and
`doctor on various instances in these procedures are
`given in Table 2.
`The approximate durability and cost of the various
`items in the Embletta® system allowed an estimate of
`the cost of a single recording, which was approximately
`€70.
`
`demand a great deal of expertise and should not be
`decentralized.
`
`In short, setting up a simple ambulatory sleep
`research unit in a private care facility is not terribly
`costly or time—consuming for respiratory physicians
`with some training in sleep medicine. It can signifi—
`cantly alter the access of patients to sleep studies and
`can take some load off the hospital sleep clinics.
`Just get to it!
`
`Discussion
`
`Increased awareness by doctors and patients on the
`deleterious effects of untreated sleep apnoea has
`created a substantial and growing demand by patients
`to access diagnostic studies and effective treatment.
`Waiting lists result when demand exceeds capacity.
`As eloquently put by Flemons et al., the demand for
`sleep studies is influenced by (i) prevalence and inci—
`dence of sleep apnoea; (ii) cost and patient reimburse—
`ment policies;
`(iii) patient and primary physician
`awareness; and (iv) waiting times. Likewise, capacity is
`dictated by (i) availability of sleep laboratory beds; (ii)
`adherence to diagnostic guidelines; (iii) availability of
`sleep specialists; and (iv) policies about who can order/
`interpret diagnostic studies (9).
`What respiratory physicians may do to balance this
`equation is limited. We have described how capacity
`may be increased in fairly simple ways. Using the
`arrangement above, most patients referred to us for
`suspected OSAS can now be evaluated within a week or
`two. The horrendous waiting times of past years is no
`more. However, the decision of the local authorities to
`restrict the number of reimbursed studies did result in
`
`the reappearance of a short waiting list in the begin—
`ning of the year, which illustrates the need for constant
`education on the requirement of such measurements.
`We emphasize the importance of a working alliance
`with a hospital sleep clinic. Although the option of
`referring a patient for an in—hospital measurement was
`not used on more then a few occasions,
`it is still
`imperative that
`this option exists. Subjects with
`daytime sleepiness but without signs of OSAS after a
`screening study should undergo a PSG, which is
`impractical to do at a private clinic, and should be
`referred to a sleep clinic. In addition, the procedure of
`CPAP titration, patient education and mask—fitting
`
`References
`
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`CPAP. Thorax. 1998;53: 414—5.
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`Snoring and breathing pauses during sleep: telephone
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`BM] 1997;3142 860—3.
`3. Young T, Evans L, Finn L, Palta M. Estimation of the
`clinically diagnosed proportion of sleep apnea syndrome
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`The occurrence of sleep—disordered breathing
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`
`7. American Academy of Sleep Medicine Task Force.
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`Th, Bjornsson E. Heimamaelingar polast betur en
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`
`64
`
`O ISSN 1752-6981
`The Clinical Respiratory Journal (2008)
`© 2007 The Authors. Journal compilation © 2007 Blackwell Publishing Ltd
`
`CONFIDENTIAL
`
`NOX0025831
`
`NOX EXHIBIT 2014-3
`
`IPR2016-01822
`
`NOX EXHIBIT 2014-3
`IPR2016-01822
`
`