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

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Device: External Nasal Dilator Strip

• Registration Number: NCT06403098
• Lead Sponsor: Florida State University

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.

Study Timeline

• Study Start: 2024-05-02
• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-03
• Study First Posted: 2024-05-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-05-02
• Study Completion: 2026-05-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
External Nasal Dilator Strip	External Nasal Dilator Strip	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.

Primary Outcome Measures

Name	Time	Method
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 low to high frequency heart rate variability ratio	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-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 Outcome Measures

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

Trial Locations

Locations (1)

Cardiovascular and Applied Physiology Laboratory; 🇺🇸 Tallahassee, Florida, United States