Comparison of CPAP Modalities for OSA Treatment

Study Overview
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Brief Summary
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This is a crossover study comparing the effect of CPAP Fixed Pressure, CPAP FLEX -PLUS and Sensawake on sleep quality, adherence to treatments, and PSG parameters in patients with moderate to severe OSA.

Detailed Description
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Obstructive sleep apnea (OSA) is associated with behavioral, cognitive, metabolic and cardiovascular conditions. Continuous Positive Airway Pressure (CPAP) is the gold standard treatment for OSA. Despite being the most effective treatment for OSA, 46 to 83% of patients do not adhere to CPAP. New technologies for CPAP treatment have been developed in order to improve patient's comfort, adherence and effectiveness in reducing apnea, hypopneas and flow limitation events. As an example, the FLEX- PLUS technology which increases inspiratory positive pressure and decreases expiratory positive pressure would soften the rhythm of breathing. Sensawake is another technology which evaluates breathing pattern changes during CPAP therapy. When the breathing pattern suggests that patient is awake, a prompt relief in pressure is activated, like ramp feature. However, it is not clear whether CPAP FLEX- PLUS or Sensawake are superior compared with fixed pressure CPAP, in terms of polysomnographic parameters, especially flow limitation or adherence to treatment. Objective: To compare the effect of fixed pressure CPAP, CPAP FLEX- PLUS and Sensawake on sleep and compliance parameters in patients with moderate to severe OSA. Methods: Fifty male patients with moderate to severe OSA will be included in a crossover design study. All patients will use each CPAP modality for 30 days in a randomized order, namely CPAP with Fixed Pressure, Flex- PLUS and Sensawake. A week of washout period will be applied between treatments. All patients will wear the same nasal mask brand. At the end of each treatment (every 4 weeks), patients will undergo polysomnography and fill out Epworth, FOSQ, Pittsburgh questionnaires and a visual analogue scale assessing CPAP side effects and patient´s comfort. Finally, adherence to CPAP modalities will be systematically checked.

Official Title
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A Crossover Study Comparing Fixed Continuous Airway Positive Pressure, FLEX- PLUS and Sensawake Modalities for OSA Treatment

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: CPAP Fixed Pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male gender apnea-hypopnea index (AHI) score of ≥20 events/hour of sleep 30-65 years-old body mass index (BMI) ≤40 Kg/m² Exclusion Criteria: major neurological, psychiatric, cardiac or respiratory disease use of psychoactive medication other sleep disorders patients referred to PSG for Bilevel, considered the need for PAP ≥ 18 cm H2O Previous contact with any OSA treatment.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a crossover study comparing different CPAP modalities in a group of patients with moderate to severe OSA.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP C- Flex-Plus by Philips Respironics<br>Four consecutive weeks with CPAP C- FLEX PLUS treatment. After these 4 weeks, patients will undergo full PSG with CPAP FLEX- PLUS. Patients will also fill out Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Functional Outcome Sleep Questionnaire, and visual analogue scale assessing CPAP side effects and patient´s comfort. Adherence to 4-week treatment will be checked. Treatment is followed by 7-day washout period. | Device: CPAP Fixed Pressure<br>* Continuous positive airway pressure (CPAP) is the gold standard treatment for moderate and severe OSA, and it has been known to apply positive pressure in the upper airways, acting as a pneumatic splint preventing the upper airway collapse during sleep. CPAP C- Flex Plus by Philips - Respironics works just as CPAP Fixed Pressure, but increases the pressure delivered in the begining of inhalation to softens the breathing rhythm of the CPAP user. CPAP with SensAwake by Fisher and Paykel works just as CPAP fixed pressure but when the breathing pattern suggests that patient is awake, a prompt relief in pressure to the lowest most comfortable level is activated, like ramp feature.<br>* Other names: CPAP with SensAwake by Fisher and Paykel;|
| Experimental: CPAP with Sensawake by Fisher and Paykel<br>Four consecutive weeks with CPAP Sensawake treatment. After these 4 weeks, patients will undergo full PSG with the same CPAP modality. Patients will also fill out Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Functional Outcome Sleep Questionnaire, and visual analogue scale assessing CPAP side effects and patient´s comfort. Adherence to 4-week treatment will be checked. Treatment is followed by 7-day washout period. | Device: CPAP Fixed Pressure<br>* Continuous positive airway pressure (CPAP) is the gold standard treatment for moderate and severe OSA, and it has been known to apply positive pressure in the upper airways, acting as a pneumatic splint preventing the upper airway collapse during sleep. CPAP C- Flex Plus by Philips - Respironics works just as CPAP Fixed Pressure, but increases the pressure delivered in the begining of inhalation to softens the breathing rhythm of the CPAP user. CPAP with SensAwake by Fisher and Paykel works just as CPAP fixed pressure but when the breathing pattern suggests that patient is awake, a prompt relief in pressure to the lowest most comfortable level is activated, like ramp feature.<br>* Other names: CPAP with SensAwake by Fisher and Paykel;|
| Active Comparator: CPAP fixed pressure<br>Four consecutive weeks with CPAP fixed pressure treatment. After these 4 weeks, patients will undergo full PSG with the same CPAP modality. Patients will also fill out Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Functional Outcome Sleep Questionnaire, and visual analogue scale assessing CPAP side effects and patient´s comfort. Adherence to 4-week treatment will be checked. Treatment is followed by 7-day washout period. | Device: CPAP Fixed Pressure<br>* Continuous positive airway pressure (CPAP) is the gold standard treatment for moderate and severe OSA, and it has been known to apply positive pressure in the upper airways, acting as a pneumatic splint preventing the upper airway collapse during sleep. CPAP C- Flex Plus by Philips - Respironics works just as CPAP Fixed Pressure, but increases the pressure delivered in the begining of inhalation to softens the breathing rhythm of the CPAP user. CPAP with SensAwake by Fisher and Paykel works just as CPAP fixed pressure but when the breathing pattern suggests that patient is awake, a prompt relief in pressure to the lowest most comfortable level is activated, like ramp feature.<br>* Other names: CPAP with SensAwake by Fisher and Paykel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow limitation | Flow limitation in percentage of total sleep time. The flow limitation will be assessed by the flow curve obtained in the polysomnographic recording. | 4 weeks after each CPAP modality completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to CPAP treatment | Adherence to CPAP treatment will be evaluated by CPAP SD card download data | 4 weeks after each CPAP modality completion | 
| Arousal index | Number of arousals per hour of sleep assessed by polysomnographic recording | 4 weeks after each CPAP modality completion | 
| Wake time after sleep onset | Wake time after sleep onset assessed by polysomnographic recording | 4 weeks after each CPAP modality completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Apnea, CPAP