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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Device: External Nasal Dilator Strip

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph D Vondrasek, MS; Phone Number: (850) 644-1281; Email: jdv22e@fsu.edu

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Recruiting
      • Cardiovascular and Applied Physiology Laboratory
      • Contact: Joseph Watso, PhD; Phone Number: 850-644-1281; Email: jwatso@fsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No External Nasal Dilator Strip; 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.
Experimental: 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.	Device: External Nasal Dilator Strip; Participants will wear an extra strength Breathe Right nasal strip overnight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	Immediate post-waking for 14 consecutive days (7 per condition).

Collaborators and Investigators

• Sponsor: Florida State University
• Investigators: Principal Investigator: Joseph Watso, PhD, Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Estimated): May 2, 2026
• Study Completion (Estimated): May 2, 2026

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00004863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate data and/or material transfer agreement approvals.
• IPD Sharing Time Frame: One year after completion of the trial, indefinitely
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No