Clinical trial NCT06403098: The Effects of External Nasal Dilator Strips on Sleep and Cardiovascular Health
Official title: The Effects of External Nasal Dilator Strips on Sleep and Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weekly averaged systolic blood pressure
timeFrame: Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions.
measure: Weekly averaged diastolic blood pressure
timeFrame: Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions.
measure: Weekly average low to high frequency heart rate variability ratio
timeFrame: Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions.
measure: Weekly averaged Heart rate
timeFrame: Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions.
Secondary outcomes:
measure: Weekly averaged sleep efficiency
timeFrame: During sleep for 14 consecutive days (7 per condition).
measure: Weekly averaged self-rated sleep quality
timeFrame: Immediate post-waking for 14 consecutive days (7 per condition).
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Cardiovascular and Applied Physiology Laboratory
state: Florida
Study officials:
affiliation: Florida State University
name: Joseph Watso, PhD
role: PRINCIPAL_INVESTIGATOR
References: