Sleep Apnea, Obstructive
Conditions
Keywords
Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure
Brief summary
Nasal Continuous Positive Airway Pressure (CPAP) is the standard therapy for obstructive sleep apnea hypopnea syndrome (OSAHS). This is most commonly administered as a single positive pressure that has been individualized for the patient to prevent obstructive respiratory events. However, the therapeutic pressure may vary by sleep stage and body position within a single night and may change over the course of several nights. One approach to dealing with this variability is the use of automatically adjusting CPAP that responds to patient breathing patterns with alterations in the delivered pressure. This study is designed to determine the effectiveness of using the energy spectrum analysis of flow signals to automatically adjust CPAP pressure and improve sleep variables. Thirty subjects who require CPAP will be recruited from the NYU sleep disorders center. Following diagnostic studies (either split night or full night) the subject will undergo a night of treatment with the Fisher and Paykel Healthcare AutoPAP. Efficacy of treatment will be evaluated based on normalization of sleep disordered breathing while treated with the AutoPAP.
Interventions
The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* AHI \>15 on the diagnostic portion of the study * \>18 years of age
Exclusion criteria
* Significant Central Apnea * Congestive Heart Failure * Inability to give informed consent * Patient intolerance to CPAP * Anatomical or physiological conditions making CPAP therapy inappropriate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index (AHI) | 1 night | The Apnea Hypopnea Index (AHI) measure of severity of Obstructive Sleep Apnea (OSA). It is a calculation of the number of apnea events and the number of hypopnea events divided by the total sleep time. Mild OSA is characterized between 5-15 events per hour. Moderate OSA is characterized as 15-30 events per hour. Severe OSA is characterized as greater than 30 events per hour. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Time With Less Than 90% Oxygen Saturation | 1 Night | Oxygen saturation is a measurement of the amount of oxygen present in the blood. An oxygen saturation of less than 90% is considered low, resulting in hypoxemia. Normal blood oxygen level is considered between 95-100%. |
| Respiratory Disturbance Index (RDI) | 1 Night | Similar to AHI, the RDI is a calculation of the total number of respiratory disturbances in sleep. The calculation includes apneas and hypopneas, but also includes respiratory effort related arousals. |
| Arousal Index (AI) | 1 Night | The Arousal Index is a calculation of the frequency of awakenings per hour of sleep. The higher the number, the more awakenings per hour. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Titration Night Treatment with the Fisher & Paykel Sleep Style 200 Auto CPAP device
SleepStyle 200 Auto Series CPAP Humidifier: The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Titration Night | — |
|---|---|---|
| Age, Continuous | 51 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 21 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 21 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 6 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Apnea Hypopnea Index (AHI)
The Apnea Hypopnea Index (AHI) measure of severity of Obstructive Sleep Apnea (OSA). It is a calculation of the number of apnea events and the number of hypopnea events divided by the total sleep time. Mild OSA is characterized between 5-15 events per hour. Moderate OSA is characterized as 15-30 events per hour. Severe OSA is characterized as greater than 30 events per hour.
Time frame: 1 night
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Titration Night | Apnea Hypopnea Index (AHI) | 2.4 events per hour |
Secondary
Arousal Index (AI)
The Arousal Index is a calculation of the frequency of awakenings per hour of sleep. The higher the number, the more awakenings per hour.
Time frame: 1 Night
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Titration Night | Arousal Index (AI) | 16.2 events per hour |
Secondary
Percent of Time With Less Than 90% Oxygen Saturation
Oxygen saturation is a measurement of the amount of oxygen present in the blood. An oxygen saturation of less than 90% is considered low, resulting in hypoxemia. Normal blood oxygen level is considered between 95-100%.
Time frame: 1 Night
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Titration Night | Percent of Time With Less Than 90% Oxygen Saturation | 1.4 percentage of total sleep time |
Secondary
Respiratory Disturbance Index (RDI)
Similar to AHI, the RDI is a calculation of the total number of respiratory disturbances in sleep. The calculation includes apneas and hypopneas, but also includes respiratory effort related arousals.
Time frame: 1 Night
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Titration Night | Respiratory Disturbance Index (RDI) | 7.1 events per hour |