Trial Outcomes & Findings for Effect of Added Varnum Mouthpiece on Pharyngeal Collapsibility and Sleep Apnea Severity in Mouth Breathers. (NCT NCT02738255)

Last Updated: 2022-04-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

26 participants

Primary outcome timeframe

Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece

Results posted on

2022-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Polysomnogram With Varnum First, Regular Polysomnogram Second 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.	Regular Polysomnogram First, Polysomnogram With Varnum Second 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.
Overall Study STARTED	11	15
Overall Study COMPLETED	11	14
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Only simple snorers with AHI\<10 were analyzed for this outcome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Polysomnogram With Varnum First, Regular Polysomnogram Second n=11 Participants 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.	Regular Polysomnogram First, Polysomnogram With Varnum Second n=15 Participants 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 n=26 Participants Total of all reporting groups
Age, Continuous	54.2 years STANDARD_DEVIATION 13.4 • n=11 Participants	55.3 years STANDARD_DEVIATION 8.1 • n=15 Participants	54.8 years STANDARD_DEVIATION 10.4 • n=26 Participants
Sex: Female, Male Female	2 Participants n=11 Participants	9 Participants n=15 Participants	11 Participants n=26 Participants
Sex: Female, Male Male	9 Participants n=11 Participants	6 Participants n=15 Participants	15 Participants n=26 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=11 Participants	0 Participants n=15 Participants	0 Participants n=26 Participants
Race (NIH/OMB) Asian	1 Participants n=11 Participants	0 Participants n=15 Participants	1 Participants n=26 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=11 Participants	0 Participants n=15 Participants	0 Participants n=26 Participants
Race (NIH/OMB) Black or African American	3 Participants n=11 Participants	4 Participants n=15 Participants	7 Participants n=26 Participants
Race (NIH/OMB) White	7 Participants n=11 Participants	11 Participants n=15 Participants	18 Participants n=26 Participants
Race (NIH/OMB) More than one race	0 Participants n=11 Participants	0 Participants n=15 Participants	0 Participants n=26 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants	0 Participants n=15 Participants	0 Participants n=26 Participants
Region of Enrollment United States	11 participants n=11 Participants	15 participants n=15 Participants	26 participants n=26 Participants
Apnea-Hypopnea Index	17.0 Events/hour STANDARD_DEVIATION 14.3 • n=11 Participants	25.5 Events/hour STANDARD_DEVIATION 18.1 • n=15 Participants	21.9 Events/hour STANDARD_DEVIATION 16.8 • n=26 Participants
Snoring Index	36.0 Events/hour STANDARD_DEVIATION 57.9 • n=5 Participants • Only simple snorers with AHI\<10 were analyzed for this outcome	331.2 Events/hour STANDARD_DEVIATION 271.7 • n=3 Participants • Only simple snorers with AHI\<10 were analyzed for this outcome	146.7 Events/hour STANDARD_DEVIATION 215.3 • n=8 Participants • Only simple snorers with AHI\<10 were analyzed for this outcome

PRIMARY outcome

Timeframe: Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece

Outcome measures

Outcome measures
Measure	Polysomnogram With Varnum Mouthpiece n=25 Participants Varnum mouthpiece, similar to a mouth tape with central opening	Regular Polysomnogram n=25 Participants Overnight sleep study without Varnum mouthpiece
Sleep Apnea Severity as Measured by Apnea-hypopnea Index (AHI)	16.4 Events/hour Interval 2.1 to 34.7	15.8 Events/hour Interval 1.1 to 29.9

SECONDARY outcome

Timeframe: Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece

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.

Outcome measures

Outcome measures
Measure	Polysomnogram With Varnum Mouthpiece n=25 Participants Varnum mouthpiece, similar to a mouth tape with central opening	Regular Polysomnogram n=25 Participants Overnight sleep study without Varnum mouthpiece
Pharyngeal Collapsibility as Measured by Median Peak Inspiratory Flow During Sleep	0.32 L/s Interval 0.1 to 0.4	0.36 L/s Interval 0.16 to 0.39

SECONDARY outcome

Timeframe: Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece

Population: This outcome was only calculated for simple snorers with AHI\<10 events/hour.

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.

Outcome measures

Outcome measures
Measure	Polysomnogram With Varnum Mouthpiece n=8 Participants Varnum mouthpiece, similar to a mouth tape with central opening	Regular Polysomnogram n=8 Participants Overnight sleep study without Varnum mouthpiece
Snoring Index in Simple Snorers	3.0 Snore/hour Interval 1.0 to 10.6	30.4 Snore/hour Interval 12.3 to 198.8

Adverse Events

Polysomnogram With Varnum Mouthpiece

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Regular Polysomnogram

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew Wellman

Brigham and Women's Hospital

Phone: 6174078483

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place