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Completed

NCT Number: NCT06403098

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.

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Key information

Conditions

Healthy

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular and Applied Physiology Laboratory

Tallahassee, Florida, 32306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

External Nasal Dilator Strip

Device

Participants will wear an extra strength Breathe Right nasal strip overnight.

Primary outcomes

  1. Weekly Averaged Systolic Blood Pressure

    Time frame: 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).

  2. Weekly Averaged Diastolic Blood Pressure

    Time frame: 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).

  3. Weekly Average Standard Deviation of Normal-to-normal R-to-R Intervals (SDNN)

    Time frame: 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.

  4. Weekly Averaged Heart Rate

    Time frame: 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 outcomes

  1. Weekly Averaged Sleep Efficiency (%)

    Time frame: 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.

  2. Weekly Averaged Self-rated Sleep Quality

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 7, 2024
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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