In Home Assessment of Three Anti-Snoring Devices, a Cross Over Study
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03333876 |
Recruitment Status :
Completed
First Posted : November 7, 2017
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
|
Sponsor:
Philips Respironics
Information provided by (Responsible Party):
Philips Respironics
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Snoring |
Interventions |
Device: Nasal Dilator Device: Mandibular Advancement Device: Positional Therapy |
Enrollment | 58 |
Participant Flow
Recruitment Details | 58 participants at one site were consented in October 2017 in Pittsburgh, Pennsylvania. 29 were snorers, 29 were bed partners. |
Pre-assignment Details | Of the 29 couples, 2 participants screened out. Therefore 27 participants started the study. |
Arm/Group Title | All Study Participants | ||
---|---|---|---|
![]() |
All study participants that consented are included in the participant flow. | ||
Period Title: Screening Period | |||
Number of participants | Number of units (partners) | ||
Started | 58 | 29 | |
Completed | 54 | 27 | |
Not Completed | 4 | 2 | |
Reason Not Completed | |||
Screen Failure | 4 | ||
Period Title: Nasal Dilator | |||
Number of participants | Number of units (partners) | ||
Started | 54 | 27 | |
Completed | 48 | 24 | |
Not Completed | 6 | 3 | |
Reason Not Completed | |||
Bed Partner Lost to follow up | 6 | ||
Period Title: Mandibular Advancement | |||
Number of participants | Number of units (partners) | ||
Started | 54 | 27 | |
Completed | 50 | 25 | |
Not Completed | 4 | 2 | |
Reason Not Completed | |||
Adverse Event | 2 | ||
Product Damage | 2 | ||
Period Title: Positional Therapy | |||
Number of participants | Number of units (partners) | ||
Started | 54 | 27 | |
Completed | 54 | 27 | |
Not Completed | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Snorers | Bed Partners | Total | |
---|---|---|---|---|
![]() |
All participants that entered the study that were considered snorers. | All participants that entered the study that were considered bed partners. | Total of all reporting groups | |
Overall Number of Baseline Participants | 29 | 29 | 58 | |
![]() |
This is all participants that were consented and eligible to participant in the study, all baseline demographics include snorer and bed partner with the exception of neck circumference and Body Mass Index (BMI).
|
|||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 29 participants | 29 participants | 58 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
29 100.0%
|
29 100.0%
|
58 100.0%
|
|
>=65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 29 participants | 29 participants | 58 participants | |
43.6 (7.5) | 43.8 (8.3) | 43.7 (8.0) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 29 participants | 29 participants | 58 participants | |
Female |
9 31.0%
|
16 55.2%
|
25 43.1%
|
|
Male |
20 69.0%
|
13 44.8%
|
33 56.9%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 29 participants | 29 participants | 58 participants | |
Hispanic or Latino |
1 3.4%
|
1 3.4%
|
2 3.4%
|
|
Not Hispanic or Latino |
28 96.6%
|
28 96.6%
|
56 96.6%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 29 participants | 29 participants | 58 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
3 10.3%
|
5 17.2%
|
8 13.8%
|
|
White |
23 79.3%
|
24 82.8%
|
47 81.0%
|
|
More than one race |
2 6.9%
|
0 0.0%
|
2 3.4%
|
|
Unknown or Not Reported |
1 3.4%
|
0 0.0%
|
1 1.7%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||
United States | Number Analyzed | 29 participants | 29 participants | 58 participants |
29 | 29 | 58 | ||
Body Mass Index (BMI)
[1] Mean (Standard Deviation) Unit of measure: Kg/m^2 |
||||
Number Analyzed | 27 participants | 0 participants | 27 participants | |
31.1 (6.5) | 31.1 (6.5) | |||
[1]
Measure Analysis Population Description:
This only includes snorers. As BMI is an important data element for the snoring group. However, provides no value for bed partner. This also excludes the two participants there were found not eligible for the study. |
||||
Neck Circumference
[1] Mean (Standard Deviation) Unit of measure: Inches |
||||
Number Analyzed | 29 participants | 0 participants | 29 participants | |
16 (1.5) | 16 (1.5) | |||
[1]
Measure Analysis Population Description:
This only includes snorers. As Neck Circumference is an important data element for the snoring group. However, provides no value for bed partner. This also excludes the two participants there were found not eligible for the study. |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Noah Papas |
Organization: | Philips Respironics |
Phone: | 4122776436 |
EMail: | Noah.Papas@philips.com |
Responsible Party: | Philips Respironics |
ClinicalTrials.gov Identifier: | NCT03333876 |
Other Study ID Numbers: |
SRC-AI-SilentNight-10090 |
First Submitted: | October 30, 2017 |
First Posted: | November 7, 2017 |
Results First Submitted: | December 11, 2018 |
Results First Posted: | February 15, 2019 |
Last Update Posted: | February 15, 2019 |