The Effects of External Nasal Dilator Strips on Sleep and Cardiovascular Health

Healthy Clinical Trial

Official title:

The Effects of External Nasal Dilator Strips on Sleep and Cardiovascular Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06403098
• Other study ID #: STUDY00004863
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: May 2, 2026

Study information

• Verified date: May 2024
• Source: Florida State University
• Contact: Joseph D Vondrasek, MS
• Phone: (850) 644-1281
• Email: jdv22e[@]fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2, 2026
• Est. primary completion date: May 2, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• External Nasal Dilator Strip
Participants will wear an extra strength Breathe Right nasal strip overnight.

Locations

Country	Name	City	State
United States	Cardiovascular and Applied Physiology Laboratory	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Secondary	Weekly averaged sleep efficiency	Wrist-based actigraphy outcome during sleep tracking.	During sleep for 14 consecutive days (7 per condition).
Secondary	Weekly averaged self-rated sleep quality	Self-rated sleep quality on a 5-point Likert scale (1=very poor, 5=very good.	Immediate post-waking for 14 consecutive days (7 per condition).