Comparison of CPAP Modalities for OSA Treatment

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03212209
• Other study ID #: AssociacaoFIP
• Status: Recruiting
• Phase: N/A
• First received: May 5, 2017
• Last updated: December 16, 2017
• Start date: April 28, 2017
• Est. completion date: July 16, 2018

Study information

• Verified date: July 2017
• Source: Associação Fundo de Incentivo à Pesquisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 16, 2018
• Est. primary completion date: February 14, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP Fixed Pressure
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.

Locations

Country	Name	City	State
Brazil	Evelyn Brasil	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Associação Fundo de Incentivo à Pesquisa	Fisher and Paykel Healthcare, Philips Respironics

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adherence to CPAP treatment	Adherence to CPAP treatment will be evaluated by CPAP SD card download data	4 weeks after each CPAP modality completion
Secondary	Arousal index	Number of arousals per hour of sleep assessed by polysomnographic recording	4 weeks after each CPAP modality completion
Secondary	Wake time after sleep onset	Wake time after sleep onset assessed by polysomnographic recording	4 weeks after each CPAP modality completion