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OpenTrials
Completed

NCT Number: NCT04427111

Therapeutic Efficiency of Mandibular Advancement Device Using Smartphone Sleep Applications and Pulse Oximeter

An observational clinical trial in a single centre. The objective of this study was to determine the efficacy of mandibular advancement device (MAD) therapy on snoring intensity, frequency, and oxygen desaturation periods in mild-moderate obstructive sleep apnea (OSA) patients with snoring problems. Totally, 18 mild-moderate OSA patients (8 females and 10 males) with subjective snoring complaint were selected. Each patient's diagnostic polysomnographic analysis (PSG) was accepted as initial PSG values. Each patient was subjected simple pulse oximeter (SPO) and smartphone sleep application (SSA) at 3 different nights at home. Diagnostic mean values of oxygen desaturation index (obtained by using SPO), snoring intensity score (obtained by using SSA), and snoring percentage (obtained by using SSA) were recorded. Non-titratable-customized MAD with 60-75% of maximal mandibular protrusion were fabricated. The patients were instructed to wear their MAD every night. SPO and SSA measurement were repeated at the 1st, 4th, 12th, and 24th week of the treatment process. At the 24th week of treatment, The PSG were repeated and all PSG, SPO, and SSA values were compared with initial diagnostic values.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Snoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • mild-moderate OSA patients with subjective snoring complaints

Exclusion criteria

  • Severe OSA
  • Undergone previous surgical therapy for SS or OSA
  • High-risk of cardiovascular, respiratory, neurological, or psychiatric disorders
  • Inadequate dental anchor for MAD treatment
  • Temporomandibular joint dysfunction
  • Angle Class III maxillomandibular relation

Treatment and study plan

Non-titratable-customized mandibular advancement device

Device

The most comfortable protruded mandibular position situated between 60-75% of MMPV was determined according to patient response with 6mm of the vertical interocclusal dimension between maxillary and mandibular central incisors and registered. The upper and lower acrylic resin splints were secured to each other in the posterior region with auto polymerizing acrylic resin and NTC-MADs were obtained. The patients were instructed to wear their non-titratable-customized mandibular advancement device every night.

Primary outcomes

  1. Change from Baseline Apnea-Hypopnea Index (AHI) at 6 months

    Time frame: at baseline and in 6 months

    AHI was defined as total number of apnea or hypopnea events which lasts for at least ten seconds per hour during full nigth polysomnography (PSG) and accepted to be the main physiological sleep parameter in the present study. The AHI values were used for the evaluation of the severity of OSA and the MAD's treatment success in OSA patients

Secondary outcomes

  1. Oxygen-desaturation index (ODI)

    Time frame: at baseline and in 6 months

    ODI was used to evaluate the desaturation fluctuations during full night PSG. ODI is defined as 3-4% decrease in oxygen saturation per hour.

  2. Snoring index (SI)

    Time frame: at baseline and in 6 months

    SI was used to evaluate snoring events per hour during PSG

  3. Simple pulse oximeter (SPO)/ODI

    Time frame: at baseline and 1, 4, 12, and 24 week of MAD treatment

    SPO/ODI was used to evaluate the desaturation fluctuations during sleep in-home environment by using simple pulse oximeter device

  4. Smartphone sleep application (SSA)/snoring intensity score (SIS)

    Time frame: at baseline and 1, 4, 12, and 24 week of MAD treatment

    SSA/SIS was used to evaluate snoring intensity that was calculated by SSA during sleep in-home environment. No information exists about how to calibrate the SSA to calculate SIS

  5. SSA/snoring percentage (SP)

    Time frame: at baseline and 1, 4, 12, and 24 week of MAD treatment

    SSA/SP was the ratio of total snoring time to total sleep time that was calculated by SSA during sleep in-home environment. No information exists about how to calibrate the SSA to calculate SP.

Sponsors and collaborators

Lead sponsor

Bahadır EZMEK

Other

Registry information

Official study title

Therapeutic Efficiency Analyses of Mandibular Advancement Devices on Obstructive Sleep Apnea Using Polysomnography, Smartphone Sleep Applications, and Simple Pulse Oximeter

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 11, 2020
Registry last updated
Jun 11, 2020

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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