Sleep Disordered BreathingNCT01062854
Effects of Earplugs on Sleep and Sleep Apnea
A study testing Soft earplugs are worn during sleep study in people with Sleep Disordered Breathing, run by University of Michigan at 1 site in United States.
Trial summary
The main goal of this study is to assess whether use of earplugs has any effect on sleep, sleep apnea, and daytime sleepiness in individuals who snore. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disordered Breathing
- What is being tested?
- Soft earplugs are worn during sleep study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, ages 18 or older
- Scheduled at the University of Michigan Sleep Disorders Center for a diagnostic polysomnogram to evaluate for sleep-disordered breathing
Who cannot join
- Medical, psychiatric or other conditions that would interfere with interpretation of the results of the sleep studies or the subject's ability to complete the Stanford Sleepiness Scale
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Sleep Disorders Center
Ann Arbor, Michigan, 48109
About this study
The main goal of this study is to assess whether use of earplugs has any effect on sleep, sleep apnea, and daytime sleepiness in individuals who snore.
- Conditions
- Sleep Disordered Breathing
- Being tested
- Soft earplugs are worn during sleep study
- Keywords
- snoring, sleep disordered breathing, polysomnography, sleep fragmentation
- Medical subject headings
- Sleep Apnea Syndromes, Snoring, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft earplugs are worn during sleep studyOther
Also called Howard Leight (Sperian) Max-1/3303361 uncorded earplugs, NRR33, SNR 37dB
Subjects are asked to wear earplugs when possible for 3-5 nights prior to their baseline sleep study. On the night of their sleep study they are randomized to either "wears earplugs" or "no earplugs" groups.
| Study group | Role | What they receive |
|---|---|---|
| Earplugs | Experimental | Subjects randomized to this arm of the study will wear earplugs during their baseline sleep study (polysomnogram). Receives: Other: Soft earplugs are worn during sleep study |
| Comparison group | No intervention | Subjects randomized to the comparison arm will not wear earplugs during their baseline sleep study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep measures (rates of apneas and hypopneas, oxygen desaturation, arousals, sleep stages, respiratory cycle-related EEG changes [RCREC])
Measured: up to 2 years after the sleep study
Secondary outcomes (1)
Subjective sleepiness measures (Stanford Sleepiness Scale)
Measured: on awakening after the sleep study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startNov 2008
- Primary completionAug 2010
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Disordered BreathingStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald D. Chervin, M.D., M.S., University of Michigan
- Investigators
- Ronald D Chervin, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062854
- Sponsor's protocol ID
- HUM00023548
- Status last verified
- Dec 2016
- First submitted
- 3 Feb 2010
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Chirakalwasan N, Ruzicka DL, Burns JW, Chervin RD. Do snoring sounds arouse the snorer? Sleep. 2013 Apr 1;36(4):565-71. doi: 10.5665/sleep.2546.
PubMed 23565002
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Earplugs on Sleep and Sleep Apnea
- ClinicalTrials.gov ID
- NCT01062854
- Acronym / sponsor ID
- HUM00023548
- Conditions
- Sleep Disordered Breathing
- Keywords
- snoring, sleep disordered breathing, polysomnography, sleep fragmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this study is to assess whether use of earplugs has any effect on sleep, sleep apnea, and daytime sleepiness in individuals who snore.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Earplugs | Experimental | Other: Soft earplugs are worn during sleep studySubjects randomized to this arm of the study will wear earplugs during their baseline sleep study (polysomnogram). |
| Comparison group | No intervention | –Subjects randomized to the comparison arm will not wear earplugs during their baseline sleep study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults, ages 18 or older
- Scheduled at the University of Michigan Sleep Disorders Center for a diagnostic polysomnogram to evaluate for sleep-disordered breathing
Key exclusion criteria (1 listed)
- Medical, psychiatric or other conditions that would interfere with interpretation of the results of the sleep studies or the subject's ability to complete the Stanford Sleepiness Scale
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft earplugs are worn during sleep studyAlso: Howard Leight (Sperian) Max-1/3303361 uncorded earplugs, NRR33, SNR 37dBSubjects are asked to wear earplugs when possible for 3-5 nights prior to their baseline sleep study. On the night of their sleep study they are randomized to either "wears earplugs" or "no earplugs" groups. | Other | Earplugs |
Primary outcome
Sleep measures (rates of apneas and hypopneas, oxygen desaturation, arousals, sleep stages, respiratory cycle-related EEG changes [RCREC])
Time frame: up to 2 years after the sleep study
1 secondary outcome
Subjective sleepiness measures (Stanford Sleepiness Scale)
Time frame: on awakening after the sleep study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Results publication: PubMed 23565002Chirakalwasan N, Ruzicka DL, Burns JW, Chervin RD. Do snoring sounds arouse the snorer? Sleep. 2013 Apr 1;36(4):565-71. doi: 10.5665/sleep.2546.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald D Chervin, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft earplugs are worn during sleep study in people with Sleep Disordered Breathing, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep measures (rates of apneas and hypopneas, oxygen desaturation, arousals, sleep stages, respiratory cycle-related EEG changes [RCREC]) (time frame: up to 2 years after the sleep study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01062854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016; AzTrials last refreshed its copy on 7 Nov 2026.