Comparison of the ApneaLink Air Home Sleep Testing Device to Polysomnography
Phase: NA
Conditions: Sleep-disordered Breathing
Sponsor: ResMed

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Comparison of the ApneaLink Air Home Sleep Testing Device to 
Polysomnography     
Investigational Plan
Protocol Number 
SLP-17-10-01 
Protocol Version and Date 
Version 1.0 
31 January 2018 
Sponsor 
ResMed Corp 
9001 Spectrum Center Blvd. 
San Diego, CA 92123 
Sponsor Contact 
Amy Blase 
Medical Affairs 
858-836-6715
This protocol has been written in accordance with current applicable guidelines (IDE for USA) as well as all 
other relevant additional references, medical and legal. 
The information herein is confidential and the property of ResMed Corp. It is to be used in confidence for 
the conduct of the clinical trial according to written agreement.
ClinicalTrials.gov ID: NCT03470493

  
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PROTOCOL REVISION HISTORY 
Version No. And Date 
Section 
Change 
Rationale 
Version 1.0 
31Jan18 
n/a 
n/a 
Original Release 
 
 
 

  
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Protocol Synopsis
Study Title 
Comparison of the ApneaLink Air Home Sleep Testing Device to Polysomnography     
PSG Central Scoring 
University of Florida Health Sleep Disorders Center 
Study Objectives 
Primary: 
• Demonstrate the sensitivity in diagnosing Sleep Disordered Breathing (SDB) of the 
ResMed ApneaLink Air device (AL) compared to PSG is at least 0.825 when results are 
scored using the AASM 2012 Guidelines. 
Secondary: 
• Compare AL and PSG numbers of predominant obstructive and predominant central 
events using the effort band and flow sensor per AASM 2012 and 2007 Guidelines 
• Evaluate the AL capability to accurately calculate monitoring time per AASM 2012 and 
2007 Guidelines 
• Evaluate the AL capability to accurately score hypopneas using the AASM 2012 arousal 
criterion (using monitoring time) vs PSG scoring of hypopneas 
• Estimate the positive likelihood ratio in diagnosing SDB of AL compared to PSG and 
evaluate it against a threshold of 5 per AASM 2012 and 2007 Guidelines 
Study Design 
This is a prospective, unblinded, open-label, single group study. All subjects will undergo 
concurrent ApneaLink Air testing and in-lab polysomnography. 
Selection Criteria 
Inclusion Criteria 
• Participant is 18 years of age or older 
• Participant is willing to provide informed consent 
• Participant is willing to participate in all study related procedures   
Exclusion Criteria 
• Unable to cease PAP therapy during PSG (if currently using) 
• Requires use of oxygen therapy during sleep 
• Diagnosis of untreated clinically relevant sleep disorder (other than SDB) 
• Pregnant 
• Participant is unsuitable to participate in the study in the opinion of the investigator 
Number of Participants 
75 participants total at 2 US sites 
Study Duration 
Each participant’s participation will be 1 night. The entire study is expected to take 
approximately 6 months, depending on recruitment rates. 
Study Endpoints 
Primary endpoint:   
• 
Sensitivity in diagnosing SDB of the AL device using AASM 2012 guidelines. 
Secondary endpoints: 
• The number of predominant obstructive and predominant central events using the AL 
effort band and flow sensor vs. PSG per AASM 2012 and 2007 Guidelines 
• Monitoring times from AL vs total sleep time from PSG per AASM 2012 and 2007 
Guidelines 
• Number of hypopneas using the AASM 2012 arousal criterion (using monitoring time)  
• Positive likelihood ratio in diagnosing SDB using AASM 2012 and 2007 guidelines  

  
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Contents 
 
1 
DEFINITIONS ...................................................................................................................................................... 5 
2 
BACKGROUND AND RATIONALE ......................................................................................................................... 6 
3 
OBJECTIVES ........................................................................................................................................................ 7 
3.1 
PRIMARY OBJECTIVES .............................................................................................................................................. 7 
3.2 
SECONDARY OBJECTIVES .......................................................................................................................................... 7 
4 
METHODS AND MATERIALS ............................................................................................................................... 7 
4.1 
POPULATION/PARTICIPANT SELECTION ....................................................................................................................... 7 
4.2 
STUDY DESIGN ....................................................................................................................................................... 7 
4.3 
MEASURES TAKEN TO MINIMIZE BIAS ........................................................................................................................ 8 
4.4 
ENVIRONMENT OF CLINICAL STUDY ............................................................................................................................ 8 
4.5 
NUMBER OF STUDY SITES AND PARTICIPANTS .............................................................................................................. 8 
4.6 
INCLUSION/EXCLUSION CRITERIA............................................................................................................................... 8 
4.7 
CLINICAL DEFINITIONS ............................................................................................................................................. 8 
4.8 
SAMPLE SIZE JUSTIFICATION ..................................................................................................................................... 9 
4.9 
ENDPOINTS ......................................................................................................................................................... 10 
4.10 
INVESTIGATIONAL DEVICES ..................................................................................................................................... 10 
4.11 
DATA COLLECTION METHOD AND STORAGE .............................................................................................................. 11 
4.11.1 
Data Collection ....................................................................................................................................... 11 
4.11.2 
Study Documentation ............................................................................................................................. 11 
4.11.3 
Query Generation ................................................................................................................................... 12 
4.11.4 
Data Storage........................................................................................................................................... 12 
4.11.5 
Inspection of Records .............................................................................................................................. 12 
4.11.6 
Study Files and Record Retention ........................................................................................................... 12 
4.11.7 
Regulatory Documentation .................................................................................................................... 12 
4.11.8 
Distribution of Results ............................................................................................................................ 13 
4.12 
CLINICAL STUDY PROCEDURES ................................................................................................................................ 13 
4.13 
INFORMED CONSENT ............................................................................................................................................ 13 
4.13.1 
Participant Remuneration ...................................................................................................................... 14 
5 
STATISTICAL ANALYSIS METHODS .....................................................................................................................14 
6 
MONITORING ....................................................................................................................................................15 
7 
ADVERSE EVENT MANAGEMENT .......................................................................................................................15 
8 
NON-SIGNIFICANT RISK DETERMINATION .........................................................................................................16 
9 
RISK MITIGATION/ASSESSMENT .......................................................................................................................16 
10 
STUDY CLOSE OUT .............................................................................................................................................17 
11 
CLINICAL SUPPLIES AND ACCOUNTABILITY ........................................................................................................17 
12 
SPONSOR RESPONSIBILITIES..............................................................................................................................17 
13 
REFERENCES ......................................................................................................................................................18 
 
 

  
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1 
DEFINITIONS 
 
ITEM 
DEFINITION 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AHI 
Apnea Hypopnea Index - Number of apnea and hypopnea events per hour when total sleep 
time is used 
AL 
ApneaLink Air – ResMed’s FDA cleared HSAT type III device 
BMI 
Body Mass Index 
CPAP 
Continuous Positive Airway pressure 
CSA 
Central Sleep Apnea 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
HSAT 
Home Sleep Apnea Testing 
IRB 
Institutional Review Board 
Monitoring 
Time 
Estimation of total sleep time by an HSAT device, e.g., ApneaLink Air 
OSA 
Obstructive Sleep Apnea 
PSG 
Polysomnography 
REI 
Respiratory Event Index – Number of apnea and hypopnea events per hour when 
calculated from an HSAT device 
RERA 
Respiratory Effort Related Arousal 
SAE 
Severe Adverse Event 
SDB 
Sleep Disordered Breathing 
TST 
Total Sleep Time - The amount of actual sleep time in a sleep episode; this time is equal to 
the total sleep episode less the awake time.   
 
 
 
 

  
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2 
BACKGROUND AND RATIONALE  
Sleep Disordered Breathing (SDB) is characterized by any abnormal breathing manifestation while 
asleep, including obstructive sleep apnea (OSA), central sleep apnea (CSA) and Cheyne-Stokes 
Respiration (CSR). Most recent data from the Wisconsin Sleep Cohort Study estimates sleep disordered 
breathing prevalence is 33.9% in males and 17.4% in females between the ages of 30 and 701. The 
prevalence of symptomatic OSA in the adult population has been estimated to be 4% in males and 2% 
in females2. These patients demonstrate behavioral and neuropsychological consequences to varying 
degrees, including excessive daytime sleepiness, intellectual deterioration and depression3. More 
serious consequences include arterial systemic hypertension, arterial pulmonary hypertension and 
heart disease4.  
The current gold standard for SDB diagnosis is in-laboratory polysomnography (PSG). The high demand 
for this labor intensive and time-consuming test results in patients waiting 2-10 months5 for an 
appointment. Over 80% of patients with OSA remain undiagnosed6 leaving the majority of the affected 
population with co-morbid consequences. The need for a diagnostic test that is more widely available 
and less expensive is necessary, not only to lessen the burden on sleep labs but also to provide patients 
with a diagnosis and treatment as soon as possible. 
A barrier of acceptance of Home Sleep Apnea Testing (HSAT) devices as a diagnostic test is their 
inability to accurately measure total sleep time (TST)7. Currently most HSAT devices use monitoring 
time to calculate the respiratory event index (REI) as a surrogate for apnea hypopnea index (AHI). The 
need for TST determination from a HSAT device has been suggested to further validate and expand the 
use of HSAT devices. A novel algorithm developed by ResMed, Ltd. allows the AL device to accurately 
calculate TST, however, this algorithm has not yet been validated.  
The ApneaLink Air (AL) device is a type III HSAT device. The device is capable of recording up to four 
channels of data including:  flow and snore via a nasal cannula attached to a pressure transducer, a 
respiratory effort belt, a pulse oximeter to measure pulse and oxygen saturation, and an actigraphy 
monitor to measure TST along with flow. The AL device has been validated against PSG for AHI8,9 and 
Cheyne-Stoke respiration detection10. Further validation of the effort belt is necessary to determine 
the accuracy of the AL ability to differentiate between obstructive and central apneic events.   
In 2012, the American Academy of Sleep Medicine (AASM) changed the criteria needed to score a 
hypopnea during a sleep study. Previous 2007 criteria had required a hypopnea to include a decrease 
in oronasal airflow by ≥30% from baseline for at least 10 seconds and ≥4% SpO2 desaturation11. These 
criteria have been widely accepted by healthcare providers to form the basis of reimbursement for 
patient equipment. In 2012, a change was made to this these criteria which permitted hypopneas to 
be scored with an arousal only, or an oxygen desaturation of ≥3%. This change in rules significantly 
increases the percentage of patients who may now be diagnosed with OSA, potentially by up to 40%. 
The need for HSAT devices to detect sleep arousal is now evident with the 2012 AASM update. The AL 
contains software to detect respiratory effort related arousals (RERA) and score hypopneas using the 
new 2012 AASM arousal criterion, however, the algorithm has not been validated.   

  
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3 
 OBJECTIVES  
The aim of this study is to evaluate the accuracy of the ResMed ApneaLink Air device (AL) as it compares 
to PSG.  The AASM criteria for out-of-center testing devices are used to evaluate the accuracy of AL12. 
Specifically, the sensitivity in diagnosing SDB of the ResMed ApneaLink Air device will be estimated per 
AASM 2012 guidelines and compared to the threshold of 0.825. Participants will use an AL device while 
undergoing concurrent PSG, which will be considered the gold standard for the estimate of sensitivity.  
3.1 
Primary Objectives 
The primary objective is to show that the sensitivity in diagnosing SDB of the ResMed ApneaLink Air 
device is at least 0.825 when results are scored using the AASM 2012 Guidelines. 
3.2 
Secondary Objectives 
The secondary objectives of the study are: 
• 
Compare AL and PSG numbers of obstructive and central events using the effort band and 
flow sensor per AASM 2012 and 2007 Guidelines 
• 
Evaluate the AL capability to accurately calculate monitoring time per AASM 2012 and 2007 
Guidelines 
• 
Evaluate the AL capability to accurately score hypopneas using the AASM 2012 arousal 
criterion (using monitoring time) vs PSG 
• 
Estimate the positive likelihood ratio in diagnosing SDB of AL compared to PSG and evaluate 
it per AASM 2012 and 2007 Guidelines against the threshold of 5  
4 
METHODS AND MATERIALS 
4.1 
Population/Participant Selection 
Eligible participants will be adults who are referred to a sleep lab for investigation of SDB. Only 
participants who meet the inclusion and exclusion criteria and sign the informed consent form (ICF) 
will be considered for enrollment.   
4.2 
Study Design 
This is a prospective, non-blinded, open label, single arm study to evaluate the AL ability to correctly 
score SDB compared to the gold standard diagnostic tool, in-lab PSG. All participants will meet the 
inclusion and exclusion criteria and will sign the informed consent form before any study related 
procedures are performed. All participants will wear the AL device and undergo concurrent PSG 
testing. The AL and PSG tests will only be considered evaluable if the evaluation time is ≥4 hours. 
Participants with <4 hours evaluable time will asked if they would like to repeat the test.  
The AL device will be scored automatically using both AASM 2012 and 2007 guidelines. The AL 
automatic results will be compared with the PSG using all variables identified by the study objectives.  
These variables are defined in Section 4.7. Results collected in this study may be used for further 
algorithm and product development that are outside the scope of this protocol.     
 
 

  
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4.3 
Measures Taken to Minimize Bias 
A qualified sleep scientist who is approved to score sleep studies will score all PSGs. This individual will 
not have information about the participant’s AL results.  
4.4 
Environment of Clinical Study  
Recruitment, screening, and testing will occur in an accredited Sleep Lab.  
4.5 
Number of Study Sites and Participants 
Up to 75 participants meeting the inclusion and exclusion criteria will take part in this study.  
4.6 
Inclusion/Exclusion Criteria 
Inclusion Criteria 
• 
Participant is 18 years of age or older 
• 
Participant is willing to provide informed consent 
• 
Participant is willing to participate in all study related procedures   
Exclusion Criteria 
• 
Unable to cease PAP therapy during PSG (if currently using) 
• 
Requires use of oxygen therapy during sleep 
• 
Diagnosis of uncontrolled clinically relevant sleep disorder (e.g., untreated insomnia or restless 
leg syndrome) 
• 
Pregnant 
• 
Participant is unsuitable to participate in the study in the opinion of the investigator 
 
4.7 
Clinical Definitions 
AHI/REI 
Following AASM guidelines, an apnea will be scored when there is a drop in the peak signal excursion by 
≥90% of pre-event baseline and the duration of the ≥90% drop in sensor signal is ≥10 seconds. 
Both 2007 and 2012 AASM definitions for hypopnea will be used:  
AASM 2007 - A hypopnea will be scored when the peak signal excursions drop by ≥30% of pre-event 
baseline, the duration of the ≥30% drop in signal excursion is ≥10 seconds and there is a ≥4% oxygen 
desaturation from pre-event baseline. 
AASM 2012 - A hypopnea will be scored when the peak signal excursions drop by ≥30% of pre-event 
baseline, the duration of the ≥30% drop in signal excursion is ≥10 seconds and there is a ≥3% oxygen 
desaturation from pre-event baseline or the event is associated with an arousal. 
AHI  
Apnea-hypopnea Index is derived from apneas plus hypopneas per hour of total sleep time from a PSG. 
REI  
Respiratory Event Index is derived from apneas plus hypopneas per hour of monitoring time from an HSAT.   
 
 

  
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OAI 
Following AASM guidelines, an apnea will be scored as obstructive if it meets apnea criteria and is associated 
with continued or increased inspiratory effort throughout the entire period of absent airflow. The use of both 
the monitoring time and total sleep time will be used for OAI calculation and comparison.  
CAI 
Following AASM guidelines, an apnea will be scored as central if it meets apnea criteria and is associated with 
absent inspiratory effort throughout the entire period of absent airflow. The use of both the monitoring time 
and total sleep time will be used for CAI calculation and comparison. 
Mixed apneas 
Following AASM guidelines, an apnea will be scored as mixed if it meets apnea criteria and is associated with 
absent inspiratory effort in the initial portion of the event, followed by resumption of inspiratory effort in 
the second portion of the event.  
TST 
Total Sleep Time as defined as sum of all sleep epochs from PSG between lights off and lights on.   
Monitoring Time 
Estimation of total sleep time by an HSAT device. 
RERA 
Following AASM guidelines, an event will be scored as a respiratory event related arousal (RERA) if during 
the diagnostic study there is a sequence of breaths lasting at least 10 seconds characterized by increasing 
respiratory effort or by flattening of the inspiratory portion of the nasal pressure leading to an arousal from 
sleep when the event does not qualify as an apnea or hypopnea. 
4.8 
Sample Size Justification 
The sample size for this clinical study will be up to 75 eligible participants undergoing PSG.  
Recruitment goals are as follows:  
• 
At least 30 men and at least 30 women 
• 
At least 5 participants in each of the following SDB categories (per PSG): 
o No SDB (AHI <5) 
o Mild SDB (AHI 5-14) 
o Moderate SDB (AHI 15-29) 
o Severe SDB (AHI ≥ 30) 
• 
At least 5 participants with CSA 
• 
At least 5 participants in each of the following BMI categories (applies to both men and 
women): 
o Normal BMI: < 25.0 
o Overweight BMI: 25.0 – 29.9 
o Obese: ≥ 30 
• 
At least 5 participants in each of the following race categories: 
o White 
o Black 
o Asian 

  
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The primary objective of this study is to demonstrate the sensitivity in diagnosing SDB per the AASM 
2012 guidelines.  Sensitivity will be assessed according to the AASM criteria for out-of-center testing 
devices.  The hypotheses tested are:  
𝐻𝐻0: 𝜋𝜋≤ 0.825 versus 𝐻𝐻𝐴𝐴: 𝜋𝜋>  0.825  
where 𝜋𝜋 is the sensitivity of AL in diagnosing SDB (using a cut-off of 5 events per hour as the 
threshold for SDB and AHI from PSG and REI from HSAT).  The hypothesis will be tested with an exact 
binomial test using a one-sided significance level of 0.025.  
The required sample size to achieve 80% power was estimated using PASS 14, Tests for One 
Proportion Procedure, assuming a true sensitivity of 0.95 (13 out of 13 true positives were correctly 
classified in a previous study).  To achieve an 80% probability of rejecting the null hypothesis, a 
minimum of 56 SDB participants are required. Seventy-five participants will be enrolled in order to 
meet recruitment goals. 
4.9 
Endpoints 
Primary endpoint:   
• 
Sensitivity in diagnosing SDB of the AL device using AASM 2012 guidelines. 
Secondary endpoints: 
• 
The number of predominant obstructive and predominant central events using the AL effort 
band and flow sensor vs. PSG per AASM 2012 and 2007 Guidelines 
• 
Monitoring times from AL vs total sleep time from PSG per AASM 2012 and 2007 Guidelines 
• 
Number of hypopneas using the AASM 2012 arousal criterion (using monitoring time)  
• 
Positive likelihood ratio in diagnosing SDB using AASM 2012 and 2007 guidelines 
 
4.10 Investigational Devices 
ApneaLink Air 
The ApneaLink Air is a market-released device that has been FDA-cleared (K143272) for use by Health 
Care Professionals for screening and diagnosis of SDB for adult patients. The device records the 
following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory 
effort and actigraphy. The AL uses these recordings to produce a report that may aid in the diagnosis 
of sleep disordered breathing or for further clinical investigation. 
The AL recorder is a 4-channel battery-powered HSAT device. Patients may perform the recording 
independently at home. The AL recorder and the respiratory effort sensor must be fastened with the 
re-usable belt on the patient's chest. All relevant respiratory information during sleep will be collected 
via nasal cannula, pulse oximetry adapter, actigraphy sensor and respiratory effort sensor. The 
disposable plastic nasal cannula is connected to the AL recorder and fixed at the patient's nose. The 
oximetry sensor is connected to the patient's finger. The respiratory effort sensor is connected to the 
AL recorder and held in place by the belt. The physician can generate a report containing automated 
sleep data from the device. 
See ApneaLink Air Clinician's Manual for more details. 

  
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Labeling  
Devices will be labeled to contain the information as required by relevant regulatory requirements:  
a) Sponsor name and address  
b) Serial number to identify the individual device  
c) Instruction for Use (Appendix) 
4.11 Data Collection Method and Storage  
4.11.1 Data Collection 
All data from the study will be documented via: 
• 
CRFs (Appendix) 
• 
Sleep study reports (AL and PSG reports and EDF files) 
Participant identification will be coded to maintain confidentiality 
ApneaLink Air 
The ApneaLink Air will be set up by sleep lab staff. Participants and site staff will have access to the AL 
clinical guide and AL user guide to help with set up. 
After testing is complete, reports will be generated with automatic scoring using both AASM 2007 and 
AASM 2012 Scoring rules. The raw data will be exported and saved in mmrx format. These three reports 
will be uploaded to the electronic data capture (EDC) system. 
PSG 
The PSG will be conducted on the participant following the normal procedures of the Sleep Lab. After 
testing is complete, the unscored EDF and associated technotes file for the PSG will uploaded to the 
EDC system. PSGs will be centrally scored by the University of Florida Sleep Lab. 
The recording montage should include EEG channels F4-M1, C4-M1, O2-M1, E1-M2, E2-M2, chin EMG 
(3 electrodes), ECG, nasal pressure, oronasal thermal airflow, snore, thoracic and abdominal effort 
(uncalibrated RIP), pulse rate, and pulse oximetry. It is preferred to also include channels F3-M2, C3-
M2, and O1-M2 as backup electrodes. Body position must be included in the tech notes, or body 
position sensor included, with video to confirm.   
4.11.2 Study Documentation 
Throughout the conduct of the study, all required data will be entered into the eCRF for each 
participant. The investigator should ensure the accuracy, completeness, and timeliness of the data 
reported to the Sponsor in the eCRFs and in all required reports and will be asked to sign and date 
the appropriate eCRF page(s) to verify the data collected. Data entered into the eCRF must be 
consistent with source documents. Any change or correction to an eCRF will be captured in the EDC 
system audit trail.  
The clinical site will provide study data to the Sponsor by recording data in the EDC System (21 CFR 
Part 11 compliant).  
In cases of participant-reported data, the eCRF will be the source record. 
 

  
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The site PI or designee and the clinical monitor will review completed eCRFs for accuracy, 
discrepancies, and missing information. The information entered into the eCRF will be accessible to 
the appropriate ResMed Medical Affairs personnel. 
4.11.3 Query Generation 
Any data queries will be sent to site for reconciliation via the eCRF system and final close-out will 
be from the study monitor. 
4.11.4 Data Storage 
All electronic systems used by the site and Sponsor will have adequate security to protect 
participant privacy and data integrity. All paper documentation will be locked in a secured cupboard. 
All trial data and documentation will be retained for a minimum of 15 years before it is destroyed. 
Access to data maintained in the EDC System is strictly limited to authorized personnel. 
4.11.5 Inspection of Records 
Periodically the Sponsor or representative will review the Investigator study file and the study data 
to verify compliance with applicable regulations and the protocol, and to verify accuracy of the data. 
4.11.6 Study Files and Record Retention 
The investigator must maintain adequate and accurate records as specified in Essential Documents 
for the Conduct of a Clinical Trial (E6, Section 8 of the ICH Guideline for GCP) to enable the conduct 
of the study to be fully documented and the study data to subsequently be verified. These 
documents should be classified into two separate categories: (1) investigator’s study file and (2) 
participant clinical source documents. 
Essential documents must be retained until at least 2 years after notification by the Sponsor that 
the investigations have been discontinued OR 2 years after the last approval of a marketing 
application. The investigator must notify the Sponsor prior to destroying any clinical study records. 
4.11.7 Regulatory Documentation 
Documents that must be provided to the Sponsor prior to study initiation are: 
• 
Signed, dated current (within 2 years) curriculum vitae of Investigator and Sub-
Investigator(s) 
• 
Financial disclosure for physicians and nurses 
• 
Signed (original), dated Investigator Agreement 
• 
Assurance that the IRB complies with requirements set forth in Title 21 Part 56 of the Code 
of Federal Regulations. The required documentation consists of name and address of the 
IRB, a current list of members including title, gender, occupation and any institutional 
affiliation of each member. A general assurance number from the Department of Health and 
Human Services may be substituted for this list. 
• 
Written notification (copy) to the Investigator from the IRB approving the protocol 
• 
IRB approved informed consent (copy) and any other adjunctive materials to be used in the 
study as required. 

  
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4.11.8 Distribution of Results 
Data analyses will be completed by an independent statistician and the clinical study report will be 
completed by the Sponsor.  
4.12 Clinical Study Procedures 
Visit 1 – Screening and PSG/HSAT 
1. Eligible participants will be identified at the research site via referral, electronic medical record 
search, database searches or other methods determined by the research site. 
2. Participants will be provided verbal and written information on the study, have the opportunity to 
ask any questions and will provide written informed consent if they elect to participate. 
3. The inclusion/exclusion criteria checklist is to be completed by the researcher to assess whether the 
participant is eligible to participate in the study.  
4. If eligible, the participant will be enrolled in the trial through the EDC, which will assign a coded 
identifier for the participant. 
5. Demographics form will be completed in the EDC 
6. Participants will be fitted with the AL and PSG equipment 
7. Participants will undergo an overnight PSG. Full PSG set-up, data acquisition, monitoring and 
reporting will be performed using both the AASM 2007 and 2012 criteria. At least 4 hours of recording 
will be required. Participants with <4 hours of recording time will be asked to repeat the exam. 
8. Upload de-identified (subject ID only) PSG files to the EDC system: 
a. Technotes file 
b. Scored PSG (optional) 
c. Unscored PSG 
9. Upload de-identified AL files to the EDC system: 
a. Raw AL data as an mmrx file 
b. Auto-scored report using AASM 2007 rules 
c. Auto-scored report using AASM 2012 rules 
10. Participant will be provided with a gift card for their participation. 
4.13 Informed Consent 
The consent form is written in accordance with applicable data privacy acts and FDA regulations and 
approved by the responsible Institutional Review board (IRB).  
The investigator or responsible staff will explain the nature, purpose and risks associated with the 
study. This will include information regarding testing for sleep disordered breathing. The possible 
side effects will be explained to the patient. The patient will be given sufficient time to consider the 
study’s implications before deciding whether to participate. Information materials created by the 
investigators and Sponsor must be approved by the responsible IRB prior to use. 
A signed, IRB-approved consent form must be obtained from the patient prior to the performance of 
any protocol-related testing or treatment procedures. The consent process must be performed by a 

  
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designated clinical study team member authorized by the IRB to consent patients and listed on the 
Delegation of Authority Log as having privileges to consent patients. A signed copy of the consent 
form must be maintained in the study files and a copy provided to the patient. The patient’s medical 
records should indicate study participation. 
4.13.1 Participant Remuneration 
Participants will be compensated $150 for their time and reimbursed at the standard rate for travel 
required to attend study-required visits and procedures.  
Any published and presented data will not include individually identifiable participant information.  
5 
STATISTICAL ANALYSIS METHODS  
Analysis Populations: 
All subjects who meet the inclusion and exclusion criteria and who complete at least 4 evaluable 
hours will be included in the Intention-to-Treat population (ITT).   All primary and secondary 
analyses will be generated for the ITT population.   
Primary Analysis: 
The diagnostic sensitivity of AL will be estimated as the number of participants with REI ≥ 5 events 
per hour according to AL per AASM 2012 Guidelines divided by the number of participants with AHI 
≥ 5 events per hour according to PSG.  The diagnostic sensitivity of AL will be compared to the 
threshold of 0.825 (AASM criteria for out-of-center testing devices) with an exact binomial test, using a 
significance level of 0.025.  Further a one-sided 97.5% confidence interval for the diagnostic 
sensitivity will be calculated using the Wilson score method.   
Secondary Analyses: 
To compare the numbers of predominant obstructive and predominant central events measured by 
AL and PSG, each patient will be classified as having (1) fewer than 5 events per hour, (2) 5 to 10 
events per hour, (3) 10 to 30 events per hour or (4) more than 30 events per hour.  The categories 
obtained by AL and PSG will be compared with the weighted kappa statistic.  Events will be assessed 
per both the AASM 2012 and 2007 guidelines. 
To compare the AL monitoring times to the PSG total sleep times, Bland-Altman plots will be 
constructed and the 95% limits of agreement will be calculated.   Times will be assessed per both the 
AASM 2012 and 2007 guidelines. 
To compare the number of hypopneas measured by AL and PSG, the number of hypopneas per hour 
will be categorized as follows:  (1) fewer than 5 events per hour, (2) 5 to 10 events per hour, (3) 10 
to 30 events per hour or (4) more than 30 events per hour. The categories obtained by AL and PSG 
will be compared with the weighted kappa statistic.   Events will be assessed per both the AASM 
2012 and 2007 guidelines. 
The positive likelihood ratio (the estimated sensitivity divided by 1 minus the estimated specificity) 
will also be calculated along with the associated one-sided 97.5% confidence interval.   The positive 
likelihood ratio will be compared with the threshold of 5 (AASM criteria for out-of-center testing 
devices12) using a Wald test.  The positive likelihood ratio will be calculated per the AASM 2012 and 
2007 guidelines.   

  
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AEs 
A listing of all adverse events reported for each participant enrolled in the study will be presented, 
including event description, time of occurrence, severity, outcome, action taken and relationship to 
the study. 
6 
MONITORING 
The study and devices to be used have been evaluated by the sponsor under 21 CFR Part 812. The sponsor 
has determined this to be a non-significant risk study, which is further discussed in Section 8. Accordingly, 
initial training of the clinical study team will be provided by ResMed personnel. This training will involve 
protocol review, proper use of the ResMed devices, and review of clinical study regulations. Review of 
clinical data will be performed per federal regulations for non-significant risk (abbreviated IDE) studies.   
7 
 ADVERSE EVENT MANAGEMENT 
All adverse effects/events (including SAEs) will be documented and reported in the trial report. 
Serious Adverse Events (SAE) 
A serious adverse event is defined as any untoward medical occurrence that: 
• 
results in death 
• 
is life-threatening 
• 
requires in-patient hospitalization or prolongation of existing hospitalization (voluntary 
hospitalizations for elective surgeries are not considered as serious adverse events) 
• 
results in persistent (symptomatic or moderate) or significant disability /incapacity 
• 
an important medical event; or 
• 
is a congenital anomaly/birth defect 
In the event of a serious adverse effect (event or reaction) the following notifications will be made: 
• The site will inform ResMed within 24 hours of becoming aware of the event 
• ResMed will alert the FDA according to regulations 
The decision will be made by the Chief Medical Officer, and/or the Principal Investigator as to whether 
the participant shall remain in the study and whether the study should continue. 
Non-serious adverse events (AE)  
Non-serious adverse events are defined as any untoward event that do not meet the criteria for 
serious adverse events. 
If a non-serious adverse event occurs during the trial, it will be documented, stored with that 
participant’s source documents and documented in the eCRF. 
Unanticipated Adverse Device Effects (UADE)  
Unanticipated adverse device effects (UADEs) are defined as any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or application), or any other 

  
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unanticipated serious problem associated with a device that relates to the rights, safety, or welfare 
of participants. 
Under the requirements of the FDA’s IDE Regulations, an investigator must submit to the sponsor (or 
its designee) and to the reviewing Institutional Review Board any unanticipated adverse device effect 
occurring during the study as soon as possible, but in no event later than ten (10) working days after 
the investigator first learns of the effect. 
Serious adverse device effect (SADE) 
In the event of a serious adverse device effect, as defined by ISO14155:2011, the following 
notifications will be made: 
• 
The site will notify ResMed within 24 hours of becoming aware of the event 
• 
ResMed will alert the FDA according to local regulations 
The decision will be made by the Chief Medical Officer, and/or the Principal Investigator as to whether 
the participant shall remain in the study and whether the study should continue. 
Expected Adverse Device Effects  
8 
NON-SIGNIFICANT RISK DETERMINATION 
The sponsor has determined that both the study and device are non-significant risk, based on the risk 
profile of this non-invasive device, and a review of the Code of Federal Regulations for significant risk 
devices. The following rationale is cited as determination of non-significant risk:  
The device does not meet the four elements of the definition for a significant risk device per 21 CFR 
812.3, (m) in that the device does not pose significant risk to the participant and is not an implant, does 
not support or sustain human life, and is not of substantial importance for diagnosis, curing, mitigating, 
preventing impairment to human health or treatment of sleep disordered breathing.  
This study involves FDA cleared SDB screening and diagnostic devices. The participant will be 
encouraged to contact a member of the investigator’s team for any questions or concerns. 
9 
RISK MITIGATION/ASSESSMENT 
This study is considered to be of low risk to the participant due to the fact that the participant will not 
be receiving any therapy. The sites will have access to the ResMed Medical Affairs department if any 
issues arise concerning the safety or welfare of the study participants. The site investigative staff will 
determine if any AEs have occurred at each evaluation and if the event is device or disease related; these 
events will be directly reported to the study manager at ResMed.  
Technical Observations and Protocol Deviations will also be assessed as they are reported by the sites 
to determine if an event affects the safety and welfare of the participant(s) or data integrity. 
Every effort will be made to maintain confidentiality of all participants’ records. For this study, ResMed 
may share health data with authorized users. Authorized users may include: internal employees at 

  
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ResMed, representatives of the IRB, the Food and Drug Administration (FDA) and other US governmental 
agencies. 
10 STUDY CLOSE OUT 
The sponsor requires the investigational site collects and returns all devices dispensed to the research 
site. All data should be entered into the EDC system and all queries answered at study closure. A final 
study report will be sent to Investigators and IRB after study completion or termination. 
11 CLINICAL SUPPLIES AND ACCOUNTABILITY 
ResMed will provide the ApneaLink Air and ancillary supplies for the duration of the trial. Investigational 
sites will meet all requirements for controlled access to the devices. An accurate and current accounting 
of the receipt and dispensing of the device will be maintained on an ongoing basis by the investigator 
or investigator’s designee in a device accountability log. All supplies given to the site must be returned 
to ResMed upon completion of the study.  
12 SPONSOR RESPONSIBILITIES 
The Sponsor will train study personnel on the clinical study protocol, procedures and study devices. 
Throughout the study period, the ResMed Medical Affairs representative will be available to address 
any issues that may arise. This availability includes access by phone, and/or e-mail. Additional site visits 
or conference calls may be scheduled to help the sites with the study procedures or materials. A close 
out visit may be scheduled at the end of the study to formally close the clinical study. 
 

  
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