A New Objective Titration Procedure for the Treatment of Mandibular Advancement Device in OSAHS Patients

Browse trials for

• Sleep Apnea Syndromes 2,162
• Sleep Apnea, Obstructive 2,198

Keywords

• Obstructive sleep apnea hypopnea syndrome
• Sleep monitoring
• contactless sensors
• Mandibular advancement device
• therapeutic outcomes

Sleep Apnea Syndromes

2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.

This study's planned enrollment of 60 is above the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.

Lead sponsor

Beijing Jishuitan Hospital is the lead sponsor of 43 studies on the registry; 16 are open to participants now.

Study arms

• Experimental
  objective titration procedure

  Objective titration procedure will be based on the objective diagnosis and treatment indicator AHI（Apnea-hypopnea index）which will be provided by RISMS (Remotely intelligent sleep monitoring system). SC-500TM is a comfortable contactless under-mattress sleep monitor, as a main component of the RISMS will be given to patients to collect the sleep data every night at home setting. The sleep report will be generated automatically every day providing the value of AHI and uploaded to the clinicians in real-time. The clinicians will contact the patients by phone every 3-7 days and instruct them remotely to adjust the MAD to increase the mandibular advancement by 0.25-1mm each time, according to AHI together with the self-reported evolution of symptoms. The patients will adapt this new mandibular advancement for 3-7 days and the clinicians will contact them again for further adjustment until a significant improvement of AHI and resolution of symptoms occurs.

  Procedure: titration procedure for MAD treatment

• Active comparator
  subjective titration procedure

  The subjective titration procedure in this study will be based on self-reported evolution of symptoms and physical limits of the OSAHS patients. Patients will be recalled to the hospital every 1-2 weeks and will be asked about the subjective changes such as snoring, daytime sleepiness，ache of tooth, temporomandibular pain and so on. Then, the clinicians will adjust the MAD to increase degree of mandibular advancement by 0.5-1mm each time. The patients will adapt this new mandibular advancement for 1-2 weeks and have to come back to hospital for further adjustment until an improvement or a resolution of symptoms occurs, or until the patients could not tolerate any further advancement.

  Procedure: titration procedure for MAD treatment

Interventions

• Proceduretitration procedure for MAD treatment

  The OSAHS patients referred for MAD treatment will experience either the objective titration procedure or the subjective titration procedure.

Primary outcomes

1. efficacy of MAD therapy

   The efficacy of MAD therapy is in terms of AHI (Apnea-hypopnea index) reduction compared to baseline, as well as the number of responders defined as patients with a reduction in AHI of 50% or more compared to baseline, and/or a follow-up AHI of 10 events/hour or less.

   Time frame: The parameter of AHI will be recorded at baseline before the titration and the end of the titration procedures (up to 60 days) using the same PSG device to diagnose OSAHS.

Secondary outcomes

1. titration time efficiency

   The titration time efficiency is the percentage of saved time over the prescribed time.

   Time frame: The prescribed time is 60 days. The actual titration time is the time taken from the start to the end of the titration procedures (up to 60 days). The saved time is 60 days minus actual titration day.

2. Epworth sleepiness score(ESS)

   The ESS (Epworth Sleepiness Scale) is a self-administered questionnaire that evaluates subjective daytime sleepiness in quotidian situations. The score ranges from 0 to 24 and is usually elevated in sleep apnea patients, indicating a propensity to fall asleep. The score 0 means no sleepiness at daytime, and the score 24 means serious sleepiness. Lower scores mean a better treatment outcome.

   Time frame: ESS will be determined at baseline and the end of titration procedures (up to 60 days).

3. Snore Scale(SS）

   SS （Snore Scale） is measured by A 10-point visual analogue scale (VAS) to assess the severity of snoring, with the VAS ranging from 0, representing no snoring, to 10, causing the bed partner to leave the room or sleep separately. Lower scores mean a better treatment outcome.

   Time frame: SS will be determined at baseline and the end of titration procedures (up to 60 days).

Individual participant data

Plan to share: No