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Effect of Added Varnum Mouthpiece on Pharyngeal Collapsibility and Sleep Apnea Severity in Mouth Breathers.

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ClinicalTrials.gov Identifier: NCT02738255
Recruitment Status : Completed
First Posted : April 14, 2016
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
David Andrew Wellman, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Obstructive Sleep Apnea
Intervention Device: Varnum mouthpiece
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Polysomnogram With Varnum First, Regular Polysomnogram Second Regular Polysomnogram First, Polysomnogram With Varnum Second
Hide Arm/Group Description Varnum mouthpiece, similar to a mouth tape with central opening on the first night, then a 1-week non-treatment period, then overnight sleep study with no mouthpiece Baseline sleep study without Varnum mouthpiece on the first night, then a 1-week non-treatment period, then an overnight sleep study with Varnum mouthpiece on the second night.
Period Title: Overall Study
Started 11 15
Completed 11 14
Not Completed 0 1
Arm/Group Title Polysomnogram With Varnum First, Regular Polysomnogram Second Regular Polysomnogram First, Polysomnogram With Varnum Second Total
Hide Arm/Group Description Varnum mouthpiece, similar to a mouth tape with central opening on the first night, then a 1-week non-treatment period, then overnight sleep study with no mouthpiece Baseline sleep study without Varnum mouthpiece on the first night, then a 1-week non-treatment period, then an overnight sleep study with Varnum mouthpiece on the second night. Total of all reporting groups
Overall Number of Baseline Participants 11 15 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 15 participants 26 participants
54.2  (13.4) 55.3  (8.1) 54.8  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 15 participants 26 participants
Female
2
  18.2%
9
  60.0%
11
  42.3%
Male
9
  81.8%
6
  40.0%
15
  57.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 15 participants 26 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   9.1%
0
   0.0%
1
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  27.3%
4
  26.7%
7
  26.9%
White
7
  63.6%
11
  73.3%
18
  69.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 15 participants 26 participants
11 15 26
Apnea-Hypopnea Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Events/hour
Number Analyzed 11 participants 15 participants 26 participants
17.0  (14.3) 25.5  (18.1) 21.9  (16.8)
[1]
Measure Description: Apnea-Hypopnea Index (AHI) is the metric used to diagnose and quantify the severity of sleep apnea. AHI measures the frequency of partial and complete airway obstructions during sleep.
Snoring Index   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Events/hour
Number Analyzed 5 participants 3 participants 8 participants
36.0  (57.9) 331.2  (271.7) 146.7  (215.3)
[1]
Measure Description: Snoring Index quantifies the number of breaths with snoring per hour of sleep. This was only measured in simple snorers who had an apnea-hypopnea index <10 events/hour
[2]
Measure Analysis Population Description: Only simple snorers with AHI<10 were analyzed for this outcome
1.Primary Outcome
Title Sleep Apnea Severity as Measured by Apnea-hypopnea Index (AHI)
Hide Description The number of respiratory events (apneas and hypopneas) per hour of sleep. This was measured on two nights in random order (night with Varnum mouthpiece and night without Varnum mouthpiece). The median AHI on the night with Varnum mouthpiece was then compared with median AHI on the night without Varnum mouthpiece.
Time Frame Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polysomnogram With Varnum Mouthpiece Regular Polysomnogram
Hide Arm/Group Description:
Varnum mouthpiece, similar to a mouth tape with central opening
Overnight sleep study without Varnum mouthpiece
Overall Number of Participants Analyzed 25 25
Median (Inter-Quartile Range)
Unit of Measure: Events/hour
16.4
(2.1 to 34.7)
15.8
(1.1 to 29.9)
2.Secondary Outcome
Title Pharyngeal Collapsibility as Measured by Median Peak Inspiratory Flow During Sleep
Hide Description The median peak flow during sleep was measured and compared on both nights (night with Varnum mouthpiece and night without Varnum mouthpiece). The median peak flow is a surrogate measure of upper airway collapsibility.
Time Frame Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polysomnogram With Varnum Mouthpiece Regular Polysomnogram
Hide Arm/Group Description:
Median peak flow from the night with Varnum mouthpiece
Median peak flow from the night without Varnum mouthpiece
Overall Number of Participants Analyzed 25 25
Median (Inter-Quartile Range)
Unit of Measure: L/s
0.32
(0.10 to 0.40)
0.36
(0.16 to 0.39)
3.Secondary Outcome
Title Snoring Index in Simple Snorers
Hide Description Snoring index is the number of breaths with snoring per hour of sleep. This was measured in both nights (night with Varnum mouthpiece and night without Varnum mouthpiece) only in simple snorers with AHI<10. The median of snoring index was compared between night with Varnum mouthpiece and night without Varnum mouthpiece.
Time Frame Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was only calculated for simple snorers with AHI<10 events/hour.
Arm/Group Title Polysomnogram With Varnum Mouthpiece Regular Polysomnogram
Hide Arm/Group Description:
Number of snores per hour on the night with Varnum mouthpiece
Number of snores per hour on the night without Varnum
Overall Number of Participants Analyzed 8 8
Median (Inter-Quartile Range)
Unit of Measure: Snore/hour
3.0
(1.0 to 10.6)
30.4
(12.3 to 198.8)
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Polysomnogram With Varnum Mouthpiece First Regular Polysomnogram First
Hide Arm/Group Description Overnight sleep study with Varnum mouthpiece first, overnight sleep study without Varnum mouthpiece second Overnight sleep study without Varnum mouthpiece first, overnight sleep study with Varnum mouthpiece second
All-Cause Mortality
Polysomnogram With Varnum Mouthpiece First Regular Polysomnogram First
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/15 (0.00%) 
Hide Serious Adverse Events
Polysomnogram With Varnum Mouthpiece First Regular Polysomnogram First
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Polysomnogram With Varnum Mouthpiece First Regular Polysomnogram First
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew Wellman
Organization: Brigham and Women's Hospital
Phone: 6174078483
EMail: awellman@rics.bwh.harvard.edu
Layout table for additonal information
Responsible Party: David Andrew Wellman, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02738255    
Other Study ID Numbers: 2012P000957F
First Submitted: April 12, 2016
First Posted: April 14, 2016
Results First Submitted: March 7, 2018
Results First Posted: July 3, 2018
Last Update Posted: July 3, 2018