Nasal Strips for Sleep Quality

Overseen By Joseph D Vondrasek, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Cardiovascular, Respiratory, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether using a nasal strip during sleep improves sleep quality and affects blood pressure and heart rate upon waking. Participants will either wear the nasal strip for a week or sleep without it, tracking their sleep and measuring blood pressure and heart rate variability. This study may suit individuals aged 18-30 who do not smoke, have specific health conditions, and can use a smartphone and nasal strip. As an unphased trial, it offers participants the chance to contribute to understanding how nasal strips might enhance sleep quality and overall health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this nasal strip is safe for improving sleep quality?

Research shows that nasal strips, placed on the outside of the nose, are generally safe. Studies have found that these strips can improve sleep by reducing snoring and enhancing sleep quality. These studies have reported no major side effects. Because nasal strips are applied externally, they involve no medication or chemicals, making them easy for most people to use. Many individuals use them without issues, suggesting they are a safe option for those seeking better sleep. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for improving sleep quality, such as medications or lifestyle changes, the external nasal dilator strip offers a non-invasive, drug-free option. This treatment is unique because it works by physically opening the nasal passages, potentially improving airflow during sleep. Researchers are excited about this simple yet innovative approach because it could enhance sleep quality without the side effects associated with many sleep medications. Additionally, the ease of use and immediate application could make it a convenient option for individuals seeking to improve their sleep health.

What evidence suggests that nasal strips are effective for improving sleep quality?

Research has shown that nasal strips like Breathe Right can help some people reduce snoring and improve sleep. Some studies have found that these strips ease stuffy noses and make breathing easier at night by opening the nasal passages. However, not all studies agree; some found no significant improvement in sleep or congestion compared to placebo strips. In this trial, participants in one arm will use an external nasal dilator strip during sleep to assess its impact on sleep quality, while those in the control arm will not use the strip. This will help determine the effectiveness of nasal strips, as they do not work the same for everyone. ^{1 2 3 6 7}

Who Is on the Research Team?

Joseph Watso, PhD

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

This clinical trial is open to healthy individuals interested in finding out if using nasal strips during sleep can affect their sleep quality, morning blood pressure, and heart rate variability. Specific eligibility criteria are not provided.

Inclusion Criteria

BMI <30

Able to use a nasal dilator strip

I have a smartphone and agree to download EliteHRV and OMRON apps.

Exclusion Criteria

I have a diagnosed heart, lung, brain, kidney, liver, or metabolic condition.

Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes)

I cannot breathe through my nose.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment - External Nasal Dilator Strip

Participants wear an external nasal dilator strip during sleep for 7 consecutive nights and days. They measure blood pressure and heart rate variability immediately after waking and complete a sleep diary.

1 week

Daily self-monitoring

Treatment - No External Nasal Dilator Strip

Participants follow normal activity and sleep patterns without the nasal dilator strip for 7 consecutive nights and days. They measure blood pressure and heart rate variability immediately after waking and complete a sleep diary.

1 week

Daily self-monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• External Nasal Dilator Strip

Trial Overview The study is testing whether wearing an external nasal dilator strip at night influences the quality of sleep and cardiovascular health upon waking. It measures perceived restfulness as well as objective changes in blood pressure and heart rate variability.

How Is the Trial Designed?

Group I: External Nasal Dilator Strip Experimental Treatment 1 Intervention

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.

Group II: No External Nasal Dilator Strip Active Control 1 Intervention

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 is already approved in United States, European Union, Canada for the following indications:

Approved in United States as External Nasal Dilator Strip for:

• Snoring
• Nasal Congestion
• Sleep Disorders

Approved in European Union as External Nasal Dilator Strip for:

• Nasal Obstruction
• Sleep Disorders
• Athletic Performance Enhancement

Approved in Canada as External Nasal Dilator Strip for:

• Snoring
• Nasal Congestion
• Sleep Disorders

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Published Research Related to This Trial

In a study of 70 subjects over 28 days, using a nasal dilator strip significantly improved subjective sleep quality, reduced daytime sleepiness, and enhanced breathing ease, indicating its potential effectiveness for those with chronic nasal congestion.

Objective measurements showed that the nasal dilator strip reduced nasal resistance by 39.1% during sleep, which may help decrease nocturnal awakenings, although polysomnography results were similar with and without the strip.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion. Wheatley, JR., Amis, TC., Lee, SA., et al.[2020]

A systematic review of 14 studies involving 147 patients found that nasal dilators (both internal and external) did not significantly improve key obstructive sleep apnea (OSA) outcomes like the apnea-hypopnea index (AHI) or oxygen saturation levels.

However, internal nasal dilators showed a slight reduction in the apnea index (AI) by about 4.87 events per hour, suggesting a minor benefit compared to external nasal dilators, which had minimal impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal Dilators (Breathe Right Strips and NoZovent) for Snoring and OSA: A Systematic Review and Meta-Analysis. Camacho, M., Malu, OO., Kram, YA., et al.[2018]

In a study of 59 subjects with chronic nasal congestion and sleep difficulties, both the new asymmetric butterfly-shaped nasal dilator strip and the Breathe Right Nasal Strip (BRNS) significantly improved sleep satisfaction and nasal symptoms compared to a placebo after 2 weeks of use.

The butterfly prototype showed notable improvements in sleep satisfaction by day 14 and was effective in enhancing quality of life related to nasal symptoms, indicating its potential as a viable alternative to existing nasal strips.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial. Schenkel, EJ., Ciesla, R., Shanga, GM.[2022]

In a clinical trial with 30 patients, the Breathe Right nasal strip significantly reduced maximum snoring intensity, particularly during lighter sleep stages, indicating its efficacy as a noninvasive solution for habitual snoring.

The nasal strip was found to be safe, with no serious adverse events reported, and most users experienced improved sleep quality after a brief adjustment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the external nasal dilator Breathe Right on snoring. Todorova, A., Schellenberg, R., Hofmann, HC., et al.[2022]

In two randomized controlled trials involving 270 subjects with chronic nocturnal nasal congestion, Breathe Right Nasal Strips (BRNS) did not show a significant improvement in sleep quality compared to placebo strips after 14 days of use.

Both BRNS and placebo strips were well tolerated, but the lack of significant difference in sleep-related quality of life measures suggests a strong placebo effect may have influenced the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Quality and Congestion with Breathe Right Nasal Strips: Two Randomized Controlled Trials. Noss, MJ., Ciesla, R., Shanga, G.[2020]

The external nasal dilator strip (ENDS) can effectively reduce nasal airflow resistance in some individuals, particularly those with higher resting nasal resistance, as shown in a study of 20 healthy adults.

The ENDS works by dilating the nasal valve and stabilizing the nasal walls, and its effects are enhanced when combined with a nasal decongestant, indicating a potential for improved nasal breathing during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal airflow dynamics: mechanisms and responses associated with an external nasal dilator strip. Kirkness, JP., Wheatley, JR., Amis, TC.[2022]

In a pilot study involving nine cancer patients with dyspnea, the use of external nasal dilator strips (ENDS) showed that one patient experienced significant improvement in breathing, while others reported varying degrees of relief.

Despite mixed results in dyspnea perception, the tolerability of ENDS was generally good, with seven out of nine patients choosing to continue using them, suggesting potential benefits for patients suffering from fatigue and cachexia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External nasal dilator strips (ENDS) may improve breathlessness in cancer patients. Neuenschwander, H., Molto, A., Bianchi, M.[2021]

In a 2-week study with 20 subjects who snore mildly, the use of a noninvasive external nasal dilator significantly improved breathing ease during sleep by 25.6% and reduced snoring loudness by 34%.

Participants also reported a 21.8% improvement in sleep quality and a 26% reduction in daytime sleepiness, indicating that the device effectively enhances overall sleep experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A subjective evaluation of a nasal dilator on sleep & snoring. Scharf, MB., Brannen, DE., McDannold, M.[2022]

In a study with 50 participants, all three nasal strips (BRNS and two prototypes) significantly improved nasal patency, with the prototypes showing greater improvements in nasal volume compared to the BRNS.

In a separate study with 82 participants assessing dermal tolerability over 7 nights, all strips were well tolerated with no signs of irritation, and the BRNS showed slightly better comfort ratings, although not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trials of Nasal Patency and Dermal Tolerability With External Nasal Dilators in Healthy Volunteers. Ward, J., Ciesla, R., Becker, W., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6822978/

Sleep Quality and Congestion with Breathe Right Nasal ... BRNS did not significantly improve subjective measures of sleep quality and nasal congestion compared with placebo strips in this population of chronic ...

2. sleepfoundation.org sleepfoundation.org/snoring/how-do-nasal-strips-work

How Do Nasal Strips Work? Several studies have found that Breathe Right strips and other similar nasal strips reduce snoring and improve sleep quality. However, most ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06403098

The Effects of External Nasal Dilator Strips on Sleep and ... The goal of this interventional study is to learn if wearing an external nasal dilator strip while sleeping changes objective and perceived sleep quality, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6109978/

Effects of nasal dilator strips on subjective measures ... The asymmetric butterfly prototype and BRNS clear strip significantly improved some subjective measures of nasal congestion and sleep compared with placebo.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165587613003005

Evaluation of the effectiveness of the external nasal dilator ... The results suggest that the ENDS improve maximal oxygen uptake, nasal patency and respiratory effort in healthy adolescent athletes after submaximal exercise.

6. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.6450

Nasal Dilator Strip is an Effective Placebo Intervention for ... Our data indicate that the nasal dilator strip could be used as an alternative placebo intervention in randomized controlled trials of patients with severe OSA, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03549130

A Pivotal Study to Assess the Effectiveness of Nasal Dilator ... This randomized, double-blind, parallel group, placebo-controlled study assessed subjective measures of nasal airway breathing immediately after application.