Efficacy and Safety Study of Nasal Lubricant Compared to Placebo on Snoring

NCT05031585 | Unknown

• 1 other identifier: HYP 002-21
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Pivotal clinical trial, multicenter of superiority, randomized, double-blind, parallel groups, placebo-controlled and use of nasal lubricant on snoring.

Conditions

Snoring; Sleep Disorder

Keywords

nasal lubricant; sleep; medical device

Outcome Measures

Primary Outcomes (1)

• The effect of nasal lubricant in the improvement of snoring when compared to placebo.

  For the primary endpoint, the level of continuous noise equivalent to the sound produced during sleep - LAeqT (equivalent-continuous sound pressure level), in dB(A), with a frequency filter in the weighting (sound level meter - Fusion SLM®) will be evaluated.

  30 days of medical device use

Secondary Outcomes (9)

• The effect of nasal lubricant on snoring reduction during polysomnography

  30 days of medical device use

• Nasal lubricant on snoring reduction during polysomnography

  30 days of medical device use

• Perception of snoring reduction by the partner

  30 days of medical device use

• The effect of nasal lubricant on apnea observed on polysomnography

  30 days of medical device use

• The effect of nasal lubricant on sleep quality using the standardized daytime sleepiness assessment questionnaire

  30 days of medical device use

Other Outcomes (2)

• Adverse event rate, evaluated from questioning or spontaneous reporting of serious and non-severe adverse events and findings on clinical examinations.

  Through study completion, an average of 30 days

• General participant well-being.

  Through study completion, an average of 30 days

Study Arms (2)

Intervention Group

EXPERIMENTAL

Nasal lubricant spray

Device: Roncoliv

Placebo

PLACEBO COMPARATOR

Placebo spray

Device: Placebo

Interventions

Roncoliv DEVICE

The medical device with nasal spray solution should be used 1 time a day, before bedtime, for 30 days.

Intervention Group

Placebo DEVICE

The medical device with placebo should be used 1 time a day, before bedtime, for 30 days.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have signed the informed consent form;
• Participants of both genders aged ≥ 18 years;
• Report of snoring assessed objectively through the standardized criteria in the snoring noise domain in the Berlin questionnaire;

You may not qualify if:

• History of allergy or hypersensitivity to the components of the nasal lubricant;
• Fixed nasal obstruction;
• Upper Airway Infections active or present for less than 7 days;
• Use of benzodiazepines and sleep inducing drugs;
• Under treatment for sleep apnea of any modality currently or within the past 6 months;
• Hepatic insufficiency;
• Active neoplastic disease;
• Severe sleep apnea determined by polysomnography (AHI \> 30);
• Moderate sleep apnea with presence of excessive daytime sleepiness;
• History of chemical dependence or alcohol abuse;
• Any neurological and psychiatric disease or significant laboratory finding present, unless adequately controlled with medication allowed in the protocol;
• Women who are pregnant or breastfeeding or who have the desire to become pregnant;
• History of infarction and stroke;
• Craniofacial malformation;
• BMI \> 35 Kg/m2;

Sponsors & Collaborators

• Brainfarma Industria Química e Farmacêutica S/A: lead

Study Sites (1)

Núcleo Interdisciplinar Da Ciencia Do Sono

São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Snoring; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Mental Disorders

Study Officials

• Brainfarma Indústria Química Farmacêutica

  Brainfarma Industria Química e Farmacêutica S/A

  STUDY DIRECTOR

Central Study Contacts

Cosmed Indústria de Cosméticos e Medicamentos S/A

CONTACT

+55 11 45072111; juliana.augusto@brainfarma.ind.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: September 2, 2021
• Study Start: February 18, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-03

Locations

BR (1)