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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External Nasal Dilator Strip | Device | Participants will wear an extra strength Breathe Right nasal strip overnight. |
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| Measure | Description | Time Frame |
|---|---|---|
| Weekly averaged systolic blood pressure | Brachial systolic blood pressure will be measured with an automated blood pressure monitor (OMRON BP5250). | 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). | Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions. |
| Weekly average low to high frequency heart rate variability ratio | Heart rate variability will be measured with a Polar H10 and the Elite-HRV mobile application. | 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. | Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly averaged sleep efficiency | Wrist-based actigraphy outcome during sleep tracking. | During sleep for 14 consecutive days (7 per condition). |
| Weekly averaged self-rated sleep quality | Self-rated sleep quality on a 5-point Likert scale (1=very poor, 5=very good. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Watso, PhD | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular and Applied Physiology Laboratory | Tallahassee | Florida | 32306 | United States |
Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate data and/or material transfer agreement approvals.
One year after completion of the trial, indefinitely
A formal plan identifying the intended use of the data and proper completion of appropriate data and/or material transfer agreement approvals with the study PI and their institution.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 29, 2026 |
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| Immediate post-waking for 14 consecutive days (7 per condition). |