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

Florida State University

Status: Enrolling

Conditions: Healthy

Treatments: Device: External Nasal Dilator Strip

Study type: Interventional

Funder types: Other

Identifiers

NCT06403098

STUDY00004863

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

No External Nasal Dilator Strip

No Intervention group

Description:

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.

External Nasal Dilator Strip

Experimental group

Description:

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.

Treatment:

Device: External Nasal Dilator Strip