Insomnia, Sleep-Disordered Breathing
Conditions
Brief summary
The study will determine which of two different types of positive airway pressure (PAP therapy) modes are more effective in reducing sleep breathing events in chronic insomnia patients and in decreasing insomnia severity.
Detailed description
Patients presenting to the sleep clinic with a primary complaint of insomnia will be potential participants for this study. Following diagnostic polysomnography (PSG) testing, insomnia patients diagnosed with SDB and meeting inclusion criteria will be randomized to a PAP treatment arm, CPAP or ASV. Participants will complete titration studies with their assigned PAP mode and attend clinical follow-up appointments over a 14-16 week timeframe. Titration PSG studies will assess PAP pressure needs to ensure that patients are receiving optimal therapy at all times during this study. PAP adaptation barriers will be addressed as they arise during the study, because it is important that participants are able to use PAP therapy nightly during participation in this protocol. Baseline scores on insomnia severity, sleep quality, subjective insomnia parameters, sleep related impairment, and quality of life will be compared to outcome measures at the 4 month mark. Pre-treatment and post-treatment objective improvements on sleep studies will also be compared including sleep breathing indices, sleep consolidation indices, and objective data download information.
Interventions
DEVICEAirCurve 10 ASV
Device is able to provide both ASV therapy and CPAP therapy modes.
Sponsors
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary complaint of insomnia when presenting at clinic * Diagnosis of moderate to severe insomnia through the Insomnia Severity Index (ISI) with a score ≥ 15 * Meet diagnostic criteria of Insomnia Disorder (per American Academy of Sleep Medicine) * Diagnosis of SDB, either OSA as determined by an AHI ≥ 5 events/hour or UARS with a RDI ≥ 15 events/hour and AHI \< 5 events/hour * Naïve to treatment for sleep-disordered breathing (SDB), including CPAP, APAP, ASV; mandibular repositioning devices (MRDs), and any other nasal or oral therapy with a primary indication of treating SDB * Able to fully understand study information in English and sign informed consent
Exclusion criteria
* Primary complaint of sleep-disordered breathing or issues with apneas during sleep * Severe respiratory disorder or severe sleep disorder such as restless leg syndrome (RLS), idiopathic hypersomnia, or narcolepsy * BMI \> 30 kg/m2 * Epworth Sleepiness Scale (ESS) score ≥ 10 * Frequent napping behavior, such as a few times a week or more * Anticipated changes to start or stop sedative or psychotropic medications during the course of the trial * Medical history of congestive heart failure (CHF) or other potentially unstable cardiac disease as well as chronic lung diseases or other debilitating medical conditions that manifest as more prominent in the patient's health compared to their sleep complaints * Daily use of opiate medications * Known contraindications to PAP therapy as listed in the indication for use * Requires a CPAP (fixed) pressure \> 20 cm H2O * Inability to comply with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index | Baseline and 4 months | Change in insomnia severity from baseline to 4 months as measured by subjective questionnaire. The Insomnia Severity Index has seven questions. The seven answers are added up for a total score. Scores range from 0 - 28. A higher score indicates a more severe degree of insomnia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality Rating | Baseline and 4 months | 8 point Likert scale for change in subjective sleep quality from baseline to 4 months. Lower scores indicated more positive sleep quality. A score 0 indicates excellent sleep quality, and a score of 7 indicates very poor sleep quality |
| Global Morning Rating | 4 months | Change in subjective rating from baseline to 4 months based on a 0-100% scale. Lower scores equal a more positive experience |
| Sleep Onset Latency | 4 months | Change in from baseline to 4 months in sleep onset time (minutes) |
| Wake After Sleep Onset (WASO) | 4 months | Change from baseline to 4 months for WASO in minutes |
| Sleep Efficiency | 4 months | Change from baseline to 4 months in sleep efficiency (total sleep time/time in bed) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuous Positive Airway Pressure Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes. | 29 |
| Adaptive Servo-Ventilation Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes. | 32 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patients met baseline exclusion requirem | 2 | 15 |
| Overall Study | Treatment intolerance | 2 | 4 |
| Overall Study | Withdrawal by Subject | 6 | 9 |
Baseline characteristics
| Characteristic | Continuous Positive Airway Pressure | Adaptive Servo-Ventilation | Total |
|---|---|---|---|
| Age, Continuous | 44.95 years | 45.89 years | 45.44 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 8 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 24 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 19 Participants | 23 Participants | 42 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 19 |
| other Total, other adverse events | 20 / 21 | 16 / 19 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 |
Outcome results
Primary
Insomnia Severity Index
Change in insomnia severity from baseline to 4 months as measured by subjective questionnaire. The Insomnia Severity Index has seven questions. The seven answers are added up for a total score. Scores range from 0 - 28. A higher score indicates a more severe degree of insomnia.
Time frame: Baseline and 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Positive Airway Pressure | Insomnia Severity Index | 9.29 units on a scale | Standard Deviation 6.57 |
| Adaptive Servo-Ventilation | Insomnia Severity Index | 13.21 units on a scale | Standard Deviation 5.17 |
Secondary
Global Morning Rating
Change in subjective rating from baseline to 4 months based on a 0-100% scale. Lower scores equal a more positive experience
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Positive Airway Pressure | Global Morning Rating | 15.39 units on a scale | Standard Deviation 20.03 |
| Adaptive Servo-Ventilation | Global Morning Rating | 24.33 units on a scale | Standard Deviation 13.15 |
Secondary
Sleep Efficiency
Change from baseline to 4 months in sleep efficiency (total sleep time/time in bed)
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Positive Airway Pressure | Sleep Efficiency | 0.75 percentage of time in bed | Standard Deviation 16.68 |
| Adaptive Servo-Ventilation | Sleep Efficiency | -2.85 percentage of time in bed | Standard Deviation 16.05 |
Secondary
Sleep Onset Latency
Change in from baseline to 4 months in sleep onset time (minutes)
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Positive Airway Pressure | Sleep Onset Latency | -6.09 minutes | Standard Deviation 44.39 |
| Adaptive Servo-Ventilation | Sleep Onset Latency | 7.17 minutes | Standard Deviation 26.9 |
Secondary
Sleep Quality Rating
8 point Likert scale for change in subjective sleep quality from baseline to 4 months. Lower scores indicated more positive sleep quality. A score 0 indicates excellent sleep quality, and a score of 7 indicates very poor sleep quality
Time frame: Baseline and 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Positive Airway Pressure | Sleep Quality Rating | 1.06 score on a scale | Standard Deviation 1 |
| Adaptive Servo-Ventilation | Sleep Quality Rating | 1.65 score on a scale | Standard Deviation 1.13 |
Secondary
Wake After Sleep Onset (WASO)
Change from baseline to 4 months for WASO in minutes
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Positive Airway Pressure | Wake After Sleep Onset (WASO) | 5.72 minutes | Standard Deviation 58.73 |
| Adaptive Servo-Ventilation | Wake After Sleep Onset (WASO) | -0.12 minutes | Standard Deviation 61.88 |