## Protocol Section
### Identification Module
**NCT ID:** NCT06424405

**Brief Title:** A New Objective Titration Procedure for the Treatment of Mandibular Advancement Device in OSAHS Patients

**Official Title:** A New Objective Titration Procedure Using Remotely Intelligent Sleep Monitoring System for the Treatment of Mandibular Advancement Device in OSAHS Patients

#### Organization Study ID Info
**ID:** BeijingJH
#### Organization
**Class:** OTHER
**Full Name:** Beijing Jishuitan Hospital
### Status Module
#### Completion Date
**Date:** 2025-03

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-25

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Beijing Jishuitan Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The aim of this clinical trial is to apply a new objective titration procedure in obstructive sleep apnea hypopnea syndrome (OSAHS) patients treated with mandibular advancement device (MAD), and to compare this new objective titration procedure with the subjective titration procedure which is commonly used in clinical practice. The remotely intelligent sleep monitoring system (RISMS) will be used in the new objective titration procedure. The main questions it aims to answer are:

1. The efficacy of MAD therapy after each titration procedure.
2. The titration time efficiency and the improvement of subjective symptoms after each titration procedure.

**Detailed Description:** In this study, patients diagnosed with OSAHS and referred for MAD treatment will be recruited. The amount of mandibular protrusion seems to be a key factor in the treatment of MAD. Patients will experience either of the two titration procedures to obtain the optimal mandibular protrusion. One procedure is a new objective titration procedure which will use the RISMS for the treatment of MAD, which will help the clinician instruct the titration according the objective therapeutic indicator. The other procedure is the subjective titration procedure which is commonly used in clinical practice. Finally, the researchers will compare the efficacy of the MAD therapy, the titration time efficiency and the improvement of subjective symptoms between the two titration procedures.

### Conditions Module

**Conditions:**

- Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)

**Keywords:**

- Obstructive sleep apnea hypopnea syndrome

- Sleep monitoring

- contactless sensors

- Mandibular advancement device

- therapeutic outcomes

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Procedure: titration procedure for MAD treatment

**Label:** objective titration procedure

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Procedure: titration procedure for MAD treatment

**Label:** subjective titration procedure

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- objective titration procedure

- subjective titration procedure

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

**Name:** titration procedure for MAD treatment

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** efficacy of MAD therapy

**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

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

**Measure:** titration time efficiency

**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.

**Description:** 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.

**Measure:** Epworth sleepiness score(ESS)

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

**Description:** 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.

**Measure:** Snore Scale(SS）

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

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* OSAHS patients with AHI≥15
* 18≤age≤70 years;
* Subject is capable of giving informed consent
* refusal of or noncompliance with CPAP (continuous positive airway pressure) or unwilling to undergo upper airway surgery
* Normal clinical, periodontal and temporomandibular joint examination

Exclusion Criteria:

* Active periodontal problems including tooth mobility
* active temporomandibular joint dysfunction
* Edentulous patients or Insufficient teeth to support MAD
* patients with severe unstable systemic diseases or suffering from psychiatric disorders
* Enlarged palatine tonsils (Friedman grade IV tonsils)

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** leihuijia2006@126.com

**Name:** Huijia HJ Lei, doctor

**Phone:** 8601058516688

**Phone Ext:** 7066

**Role:** CONTACT

**Contact 2:**

**Email:** xiaohan_007@163.com

**Name:** Yanwei YW Lv, doctor

**Phone:** 8658517106

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** kyc_jst@163.com

- **Name:** Si S Chen, Doctor

- **Phone:** 8601058517158

- **Role:** CONTACT

**Country:** China

**Facility:** Beijing Jishuitan Hospetal

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100035

#### Overall Officials

**Official 1:**

**Affiliation:** Beijing Jishuitan Hospital

**Name:** Si S Chen, doctor

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001049

- Term: Apnea

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000020919

- Term: Sleep Disorders, Intrinsic

- ID: D000020920

- Term: Dyssomnias

- ID: D000012893

- Term: Sleep Wake Disorders

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M4361

- Name: Apnea

- Relevance: LOW

- As Found: Unknown

- ID: M15694

- Name: Sleep Apnea Syndromes

- Relevance: HIGH

- As Found: Obstructive Sleep Apnea Hypopnea Syndrome

- ID: M22010

- Name: Sleep Apnea, Obstructive

- Relevance: HIGH

- As Found: Sleep Apnea Hypopnea Syndrome

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22242

- Name: Parasomnias

- Relevance: LOW

- As Found: Unknown

- ID: M22654

- Name: Sleep Disorders, Intrinsic

- Relevance: LOW

- As Found: Unknown

- ID: M22655

- Name: Dyssomnias

- Relevance: LOW

- As Found: Unknown

- ID: M15696

- Name: Sleep Wake Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012891

- Term: Sleep Apnea Syndromes

- ID: D000020181

- Term: Sleep Apnea, Obstructive

### Misc Info Module

- Version Holder: 2024-05-31
