HealthyNCT06403098
The Effects of External Nasal Dilator Strips on Sleep and Cardiovascular Health
A study testing External Nasal Dilator Strip in people with Healthy, run by Florida State University at 1 site in United States.
Trial summary
The goal of this interventional study is to learn if wearing an external nasal dilator strip while sleeping changes objective and perceived sleep quality, immediate post-waking blood pressure, and immediate-post waking heart rate variability. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- External Nasal Dilator Strip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2024to 16 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-30
- BMI <30
- Has a smartphone and is willing to download EliteHRV and OMRON mobile applications.
- Able to use a nasal dilator strip
Who cannot join
- Overt cardiovascular (e.g., diagnosed hypertension), respiratory, neurological, renal, liver, and/or metabolic health conditions.
- Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes).
- Currently pregnant, trying to become pregnant, or lactating.
- Inability to breathe through the nose.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular and Applied Physiology Laboratory
Tallahassee, Florida, 32306
About this study
The goal of this interventional study is to learn if wearing an external nasal dilator strip while sleeping changes objective and perceived sleep quality, immediate post-waking blood pressure, and immediate-post waking heart rate variability.
Read the detailed description
Nasal dilator strips are strips often made up of stiff plastic, placed on the lower bridge of the nose by an adhesive strip. They work by slightly pulling the nostrils and surrounding nose bridge area outward, dilating the nostrils, and decreasing air resistance. Nasal breathing is associated with lower diastolic blood pressure, an important marker of heart health, in comparison to mouth breathing. In addition to blood pressure, nasal breathing during sleep is potentially related with better sleep quality. Participating in this study will help us understand the effect nasal dilator strips have on cardiovascular and sleep health. Better understanding of the benefits of nasal dilator strips will provide important knowledge to researchers who study how the body works.
- Conditions
- Healthy
- Being tested
- External Nasal Dilator Strip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Nasal Dilator StripDevice
Participants will wear an extra strength Breathe Right nasal strip overnight.
| Study group | Role | What they receive |
|---|---|---|
| No External Nasal Dilator Strip | No intervention | The control arm will last 7 consecutive nights and days. Participants will be asked to follow normal activity and sleep patterns. Immediately after waking the participants will measure their blood pressure and heart rate variability and complete a sleep diary to characterize subjective sleep quality. A wrist-based activity monitor will measure objective sleep quality during the control arm. |
| External Nasal Dilator Strip | Experimental | The experimental arm will last 7 consecutive nights and days. Participants will be asked to follow normal activity and sleep patterns, but they will wear an external nasal dilator strip during sleep. Immediately after waking the participants will measure their blood pressure and heart rate variability and complete a sleep diary to characterize subjective sleep quality. A wrist-based activity monitor will measure objective sleep quality during the experimental arm. Receives: Device: External Nasal Dilator Strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Averaged Systolic Blood Pressure
Brachial systolic blood pressure will be measured with an automated blood pressure monitor (OMRON BP5250).
Measured: Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions.
Weekly Averaged Diastolic Blood Pressure
Brachial diastolic blood pressure will be measured with an automated blood pressure monitor (OMRON BP5250).
Measured: Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions.
Weekly Average Standard Deviation of Normal-to-normal R-to-R Intervals (SDNN)
Heart rate variability will be measured with a Polar H10 and the Elite-Heart Rate Variability (HRV) mobile application.
Measured: Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions.
Weekly Averaged Heart Rate
Heart rate will be measured with a Polar H10 and the Elite-HRV mobile application.
Measured: Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions.
Secondary outcomes (2)
Weekly Averaged Sleep Efficiency (%)
Based on self-reported in-bed, sleep, wake, and out-of-bed times, this is the percent of time sleeping relative to time in bed.
Measured: During sleep for 14 consecutive days (7 per condition).
Weekly Averaged Self-rated Sleep Quality
Self-rated sleep quality on a 6-point Likert scale (1=very poor, 6=very good).
Measured: Immediate post-waking for 14 consecutive days (7 per condition).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start2 May 2024
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Watso, Florida State University
- Investigators
- Joseph Watso, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403098
- Sponsor's protocol ID
- STUDY00004863
- Status last verified
- Jul 2026
- First submitted
- 3 May 2024
- Last updated
- 9 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate data and/or material transfer agreement approvals.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of External Nasal Dilator Strips on Sleep and Cardiovascular Health
- ClinicalTrials.gov ID
- NCT06403098
- Acronym / sponsor ID
- STUDY00004863
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Posted 9 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this interventional study is to learn if wearing an external nasal dilator strip while sleeping changes objective and perceived sleep quality, immediate post-waking blood pressure, and immediate-post waking heart rate variability.
Detailed description
Nasal dilator strips are strips often made up of stiff plastic, placed on the lower bridge of the nose by an adhesive strip. They work by slightly pulling the nostrils and surrounding nose bridge area outward, dilating the nostrils, and decreasing air resistance. Nasal breathing is associated with lower diastolic blood pressure, an important marker of heart health, in comparison to mouth breathing. In addition to blood pressure, nasal breathing during sleep is potentially related with better sleep quality. Participating in this study will help us understand the effect nasal dilator strips have on cardiovascular and sleep health. Better understanding of the benefits of nasal dilator strips will provide important knowledge to researchers who study how the body works.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No External Nasal Dilator Strip | No intervention | –The control arm will last 7 consecutive nights and days. Participants will be asked to follow normal activity and sleep patterns. Immediately after waking the participants will measure their blood pressure and heart rate variability and complete a sleep diary to characterize subjective sleep quality. A wrist-based activity monitor will measure objective sleep quality during the control arm. |
| External Nasal Dilator Strip | Experimental | Device: External Nasal Dilator StripThe experimental arm will last 7 consecutive nights and days. Participants will be asked to follow normal activity and sleep patterns, but they will wear an external nasal dilator strip during sleep. Immediately after waking the participants will measure their blood pressure and heart rate variability and complete a sleep diary to characterize subjective sleep quality. A wrist-based activity monitor will measure objective sleep quality during the experimental arm. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-30
- BMI <30
- Has a smartphone and is willing to download EliteHRV and OMRON mobile applications.
- Able to use a nasal dilator strip
Key exclusion criteria (4 listed)
- Overt cardiovascular (e.g., diagnosed hypertension), respiratory, neurological, renal, liver, and/or metabolic health conditions.
- Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes).
- Currently pregnant, trying to become pregnant, or lactating.
- Inability to breathe through the nose.
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 |
|---|---|---|
| External Nasal Dilator StripParticipants will wear an extra strength Breathe Right nasal strip overnight. | Device | External Nasal Dilator Strip |
Primary outcome
Weekly Averaged Systolic Blood Pressure
Time frame: Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions.
Brachial systolic blood pressure will be measured with an automated blood pressure monitor (OMRON BP5250).
Weekly Averaged Diastolic Blood Pressure
Time frame: Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions.
Brachial diastolic blood pressure will be measured with an automated blood pressure monitor (OMRON BP5250).
Weekly Average Standard Deviation of Normal-to-normal R-to-R Intervals (SDNN)
Time frame: Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions.
Heart rate variability will be measured with a Polar H10 and the Elite-Heart Rate Variability (HRV) mobile application.
Weekly Averaged Heart Rate
Time frame: Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions.
Heart rate will be measured with a Polar H10 and the Elite-HRV mobile application.
2 secondary outcomes
Weekly Averaged Sleep Efficiency (%)
Time frame: During sleep for 14 consecutive days (7 per condition).
Weekly Averaged Self-rated Sleep Quality
Time frame: Immediate post-waking for 14 consecutive days (7 per condition).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate data and/or material transfer agreement approvals.
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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.
Joseph Watso, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Nasal Dilator Strip in people with Healthy, run by Florida State University 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 4 inclusion and 4 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 9 Sep 2026. 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?
Yes. Results are posted in the registry (first posted 9 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weekly Averaged Systolic Blood Pressure (time frame: Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.