Healthy
Conditions
Brief 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.
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.
Interventions
DEVICEExternal Nasal Dilator Strip
Participants will wear an extra strength Breathe Right nasal strip overnight.
Sponsors
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Averaged Systolic Blood Pressure | 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 | 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) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Averaged Sleep Efficiency (%) | During sleep for 14 consecutive days (7 per condition). | 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. |
| Weekly Averaged Self-rated Sleep Quality | Immediate post-waking for 14 consecutive days (7 per condition). | Self-rated sleep quality on a 6-point Likert scale (1=very poor, 6=very good). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoseph Watso, PhD
Florida State University
Participant flow
Pre-assignment details
30 participants enrolled. One participant withdrew before randomization because she lost interest. Another withdrew because she mentioned health history information which disqualified her from the study based on our inclusion and exclusion criteria.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 22 years STANDARD_DEVIATION 3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
None listed