Obstructive Sleep Apnea
Conditions
Keywords
Obstructive sleep apnea, Efficacy, Subjective feedback, Preference
Brief summary
The purpose of this study is to assess the efficacy and user preference of the Newport AutoSet for Her in female obstructive sleep apnea (OSA) patients. Efficacy will be evaluated by comparing the apnea and hypopnea index (AHI) and oxygen desaturation index (ODI) of the Newport AutoSet for Her algorithm to a standard algorithm. User preference will be evaluated by subjective feedback relating to comfort, ease of falling asleep, sleep disturbance and feeling of being refreshed.
Interventions
An AutoSet device with a standard algorithm developed for sleep breathing parameters that are specific to a particular gender.
An AutoSet device with an algorithm developed for sleep breathing parameters specific to females.
Sponsors
The University of Western Australia
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Pre-menopausal females aged ≥ 18 years * Current positive airway pressure (PAP)(CPAP or APAP) therapy user with 'current' defined as on PAP therapy for at least 1 month prior to study entry * Diagnostic PSG available * Diagnosis of mild-moderate OSA (AHI ≤ 30) * Participants willing and able to give written informed consent
Exclusion criteria
* Participants currently using Bi-level PAP * Participants currently using supplemental oxygen * Participants who are pregnant * Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury) * Participants who the researcher believes are unsuitable for inclusion because either: * they do not comprehend English * they are unable to provide written informed consent * they are physically unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnoea Hypopnoea Index (AHI) | 1 day | Number of apnoeas and hypopnoeas per hour of sleep |
| Oxygen Desaturation Index (ODI) | 1 day | Number of oxygen desaturations per hour of sleep |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Taken to Fall Asleep | 1 day | Time in minutes taken to fall alseep |
| Number of Spontaneous Arousals | 1 day | Number of spontaneous arousals occurring over the entire total sleep time |
| Number of Hypopnoeas | 1 day | Total number of hypopnoeas occurring in the total sleep time |
| Number of Obstructive Apnoeas | 1 day | Total number of obstructive apnoeas occurring in the total sleep time |
| Sleep Efficacy | 1 day | Sleep time divided by total time available for sleep |
| Oxygen Saturation | 1 day | Oxygen saturation recorded in the total sleep time |
| Percentage of Total Sleep Time Spent in Each Sleep Stage | 1 day | Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM) |
| Number of Respiratory Event Related Arousals | 1 day | Total number of respiratory event related arousals over the entire sleep period |
| Number of Central Apnoeas | 1 day | Total number of central apnoeas occurring in the total sleep time |
| Wake After Sleep Onset Time | 1 day | Time awake in minutes after initial sleep onset |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Unblinded Investigational Arm Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase). | 5 |
| Standard AutoSet Algorithm Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night. | 10 |
| Modified AutoSet Then Standard AutoSet Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night | 10 |
| Total | 25 |
Baseline characteristics
| Characteristic | Unblinded Investigational Arm | Standard AutoSet Algorithm | Modified AutoSet Then Standard AutoSet | Total |
|---|---|---|---|---|
| Age, Continuous | 43.60 years STANDARD_DEVIATION 7.7 | 44.10 years STANDARD_DEVIATION 3.78 | 45.60 years STANDARD_DEVIATION 6.13 | 44.85 years STANDARD_DEVIATION 5.02 |
| Region of Enrollment Australia | 5 participants | 10 participants | 10 participants | 25 participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 10 Participants | 25 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 5 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Apnoea Hypopnoea Index (AHI)
Number of apnoeas and hypopnoeas per hour of sleep
Time frame: 1 day
Population: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard AutoSet Algorithm | Apnoea Hypopnoea Index (AHI) | 0.96 events/hour | Standard Deviation 1.4 |
| Modified AutoSet Algorithm | Apnoea Hypopnoea Index (AHI) | 0.91 events/hour | Standard Deviation 0.9 |
Primary
Oxygen Desaturation Index (ODI)
Number of oxygen desaturations per hour of sleep
Time frame: 1 day
Population: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard AutoSet Algorithm | Oxygen Desaturation Index (ODI) | 1.92 events/hour | Standard Deviation 1.82 |
| Modified AutoSet Algorithm | Oxygen Desaturation Index (ODI) | 2.19 events/hour | Standard Deviation 2.15 |
Secondary
Number of Central Apnoeas
Total number of central apnoeas occurring in the total sleep time
Time frame: 1 day
Population: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard AutoSet Algorithm | Number of Central Apnoeas | 3.55 Central Apnoeas | Standard Deviation 7.45 |
| Modified AutoSet Algorithm | Number of Central Apnoeas | 3.00 Central Apnoeas | Standard Deviation 3.78 |
Secondary
Number of Hypopnoeas
Total number of hypopnoeas occurring in the total sleep time
Time frame: 1 day
Population: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard AutoSet Algorithm | Number of Hypopnoeas | 1.45 Hypopneas | Standard Deviation 2.33 |
| Modified AutoSet Algorithm | Number of Hypopnoeas | 2.00 Hypopneas | Standard Deviation 3.42 |
Secondary
Number of Obstructive Apnoeas
Total number of obstructive apnoeas occurring in the total sleep time
Time frame: 1 day
Population: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard AutoSet Algorithm | Number of Obstructive Apnoeas | 1.30 Obstructive Apnoeas | Standard Deviation 4.44 |
| Modified AutoSet Algorithm | Number of Obstructive Apnoeas | 0.80 Obstructive Apnoeas | Standard Deviation 1.36 |
Secondary
Number of Respiratory Event Related Arousals
Total number of respiratory event related arousals over the entire sleep period
Time frame: 1 day
Population: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard AutoSet Algorithm | Number of Respiratory Event Related Arousals | 2.60 Respiratory-Event Related Arousals | Standard Deviation 3.32 |
| Modified AutoSet Algorithm | Number of Respiratory Event Related Arousals | 1.30 Respiratory-Event Related Arousals | Standard Deviation 1.84 |
Secondary
Number of Spontaneous Arousals
Number of spontaneous arousals occurring over the entire total sleep time
Time frame: 1 day
Population: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard AutoSet Algorithm | Number of Spontaneous Arousals | 85.55 Spontaneous Arousals | Standard Deviation 40.88 |
| Modified AutoSet Algorithm | Number of Spontaneous Arousals | 81.40 Spontaneous Arousals | Standard Deviation 33.91 |
Secondary
Oxygen Saturation
Oxygen saturation recorded in the total sleep time
Time frame: 1 day
Population: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard AutoSet Algorithm | Oxygen Saturation | 96.56 percentage SpO2 | Standard Deviation 0.78 |
| Modified AutoSet Algorithm | Oxygen Saturation | 96.31 percentage SpO2 | Standard Deviation 0.81 |
Secondary
Percentage of Total Sleep Time Spent in Each Sleep Stage
Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM)
Time frame: 1 day
Population: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard AutoSet Algorithm | Percentage of Total Sleep Time Spent in Each Sleep Stage | Time spent in N1 Sleep | 6.05 percentage of total sleep time | Standard Deviation 4.63 |
| Standard AutoSet Algorithm | Percentage of Total Sleep Time Spent in Each Sleep Stage | Time spent in N2 Sleep | 51.28 percentage of total sleep time | Standard Deviation 12.91 |
| Standard AutoSet Algorithm | Percentage of Total Sleep Time Spent in Each Sleep Stage | Time spent in N3 Sleep | 24.83 percentage of total sleep time | Standard Deviation 11.58 |
| Standard AutoSet Algorithm | Percentage of Total Sleep Time Spent in Each Sleep Stage | Time spent in REM Sleep | 17.93 percentage of total sleep time | Standard Deviation 11.05 |
| Modified AutoSet Algorithm | Percentage of Total Sleep Time Spent in Each Sleep Stage | Time spent in REM Sleep | 19.77 percentage of total sleep time | Standard Deviation 7.54 |
| Modified AutoSet Algorithm | Percentage of Total Sleep Time Spent in Each Sleep Stage | Time spent in N1 Sleep | 6.20 percentage of total sleep time | Standard Deviation 3.33 |
| Modified AutoSet Algorithm | Percentage of Total Sleep Time Spent in Each Sleep Stage | Time spent in N3 Sleep | 24.60 percentage of total sleep time | Standard Deviation 10.77 |
| Modified AutoSet Algorithm | Percentage of Total Sleep Time Spent in Each Sleep Stage | Time spent in N2 Sleep | 49.44 percentage of total sleep time | Standard Deviation 12.01 |
Secondary
Sleep Efficacy
Sleep time divided by total time available for sleep
Time frame: 1 day
Population: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard AutoSet Algorithm | Sleep Efficacy | 85.99 percentage of total recorded time | Standard Deviation 8.55 |
| Modified AutoSet Algorithm | Sleep Efficacy | 84.14 percentage of total recorded time | Standard Deviation 9.62 |
Secondary
Time Taken to Fall Asleep
Time in minutes taken to fall alseep
Time frame: 1 day
Population: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard AutoSet Algorithm | Time Taken to Fall Asleep | 16.52 minutes | Standard Deviation 19.58 |
| Modified AutoSet Algorithm | Time Taken to Fall Asleep | 16.25 minutes | Standard Deviation 12.7 |
Secondary
Wake After Sleep Onset Time
Time awake in minutes after initial sleep onset
Time frame: 1 day
Population: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard AutoSet Algorithm | Wake After Sleep Onset Time | 47.52 minutes | Standard Deviation 34.57 |
| Modified AutoSet Algorithm | Wake After Sleep Onset Time | 57.42 minutes | Standard Deviation 43.31 |