Trials / Completed
CompletedNCT02721329
Evaluation of APAP With SensAwake in OSA and Insomnia Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Fisher and Paykel Healthcare · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The hypothesis is that APAP with SensAwake improves wake-after sleep onset compared to APAP without SensAwake in a patient population with Obstructive Sleep Apnea Syndrome (OSAS) and Insomnia.
Detailed description
Patients with OSA and Insomnia will be enrolled into this randomized study to receive treatment with APAP with and without SensAwake. Baseline data will be collected for one week prior to CPAP initiation, followed by two treatment periods on each study arm of four weeks each.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | APAP | Automatic Continuous Positive Airway Pressure |
| DEVICE | APAP with SensAwake | Automatic Continuous Positive Airway Pressure with SensAwake enabled. SensAwake is a pressure relief technology that detects the transition from sleep to wake, and promptly reduces the pressure during wakeful periods. |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2020-03-01
- Completion
- 2020-03-01
- First posted
- 2016-03-29
- Last updated
- 2020-07-02
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02721329. Inclusion in this directory is not an endorsement.