Effects of Telemedical Support on Therapeutic Results of CPAP Patients

NCT05440279 | Completed

• 1 other identifier: 2947
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is a type of sleep-related breathing disorders that is characterized by a sleep-related constriction (obstruction) of the upper airways. The treatment with continuous application of positive airway pressure (CPAP) via respiratory mask forms the therapeutical standard of OSA. The autoCPAP (automatic positive airway pressure: APAP) therapy is an additional treatment option for patients with more unstable conditions (e.g. due to sleep position) which is characterized by a dynamic adaption of the applied airway pressure according to patients therapeutical needs. Device usage time and therapy adherence are crucial for treatment success. The purpose of this study is to assess the effect of a digital patient support (DPS) tool, complementary to standard care on continuous and automatic positive airway pressure (CPAP, APAP) adherence and daytime sleepiness after 12 weeks in patients diagnosed with severe obstructive sleep apnea (OSA). All patients with apnea-hypopnea index (AHI) ≥ 30 per hour are prospectively included and randomized to receive standard care (SC) or standard care with personalized DPS via prisma APP prototype version (SC+DPS). In both arms, initiation of therapy and standardized therapy control after 12 weeks is carried out identically. Patients in the SC+DPS arm received additionally automated feedback on their therapy and motivational messages, as well as therapy recommendations.

Conditions

Obstructive Sleep Apnea; Adherence, Treatment

Keywords

Interventional; randomized; adherence; continuous positive airway pressure; CPAP; telehealth; obstructive sleep apnea; digital patient support; prisma APP

Outcome Measures

Primary Outcomes (1)

• Daytime sleepiness (ESS Score)

  Significant change in daytime sleepiness of CPAP/ APAP patients with standard care plus support of a digital patient support (DPS) tool versus patients with standard care without support of a digital patient support (DPS) tool from baseline at therapy control after 12 weeks

  Baseline and after 12 weeks (Diagnosis/ baseline to therapy control)

Secondary Outcomes (9)

• Therapy adherence

  Within 12 weeks (period between diagnosis/ baseline to therapy control)

• Therapy efficacy

  Within 12 weeks (period between diagnosis/ baseline to therapy control)

• type and frequency of usage of device comfort features

  Within 12 weeks (period between diagnosis/ baseline to therapy control)

• satisfaction with therapy and care according to standardized survey

  up to 12 weeks

• Investigation of progress of therapy adherence, therapy efficacy and side effects in the intervention group

  Within 12 weeks (period between diagnosis/ baseline to therapy control)

Study Arms (2)

Standard Care (SC)

NO INTERVENTION

Treatment in the control group takes place as standard care that includes an education session with a respiratory therapist about OSA and its consequences, proper use and maintenance of the CPAP device and mask, and therapy and study expectations, provision with a fixed or auto CPAP device (prismaSMART/ prismaSOFT, Löwenstein Medical Technology GmbH \& Co. KG), a heated humidifier (prismaAQUA, Löwenstein Medical Technology GmbH \& Co. KG) if needed, and a fitting interface, the initiation of therapy with anamnesis, diagnosis night, titration night, education, etc., as well as standardized therapy control after 12 weeks.

Standard Care (SC) + digital patient support (DPS) tool

ACTIVE COMPARATOR

Treatment in the intervention group takes place as standard care (please see description of arm 1 - control group) and electronic therapy support in addition. The electronic therapy support consists of: 1. Emails to patients with personalized, automated feedback on their therapy (derived from device data received via modem or data entered by the patient via electronic questionnaire), 2. electronic questionnaires (web-based) on possible problems during therapy, personal adherence goals and subjective therapy success, 3. possibility to set personal adherence goals every week, 4. links to explanations and videos on therapy and the handling of therapy equipment and accessories, 5. provision of data for the trial center in the event of contact by the patient, as well as for routine therapy monitoring.

Device: digital patient support

Interventions

digital patient support DEVICE

Intervention takes place through a regular electronic therapy support in addition to standard care that is defined as follows: Emails to patients with personalized, automated feedback on their therapy (derived from device data received via modem or data entered by the patient via electronic questionnaire), 1. electronic questionnaires (web-based) on possible problems during therapy and subjective therapy success, 2. possibility to set personal adherence goals every week, 3. links to explanations and videos on therapy and the handling of therapy equipment and accessories, 4. provision of data for the trial center in the event of contact by the patient, as well as for routine therapy monitoring.

Standard Care (SC) + digital patient support (DPS) tool

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-80 years
• CPAP-naïve
• confirmed severe OSA (AHI \>30/h), diagnosis based on polysomnography (PSG) (MiniScreen PRO with Software MiniscreenViewer, Dr. Fenyves \& Gut, Rangendingen, Germany)
• written informed consent to participate in the study, including a data protection statement.

You may not qualify if:

• presence of a contraindication to PAP therapy
• participation in another study influencing automated electronic support
• lack of possibility to receive emails or use electronic means of communication
• lack of patient consent.

Sponsors & Collaborators

• Facharztzentrum Sonneberg-Coburg uBAG: lead
• Heinen und Löwenstein GmbH & Co. KG: collaborator

Study Sites (1)

Facharztzentrum Coburg Sonneberg

Sonneberg, Thuringia, 96515, Germany

Location

Related Publications (11)

• Antic NA, Catcheside P, Buchan C, Hensley M, Naughton MT, Rowland S, Williamson B, Windler S, McEvoy RD. The effect of CPAP in normalizing daytime sleepiness, quality of life, and neurocognitive function in patients with moderate to severe OSA. Sleep. 2011 Jan 1;34(1):111-9. doi: 10.1093/sleep/34.1.111.

  PMID: 21203366 BACKGROUND

• Budhiraja R, Parthasarathy S, Drake CL, Roth T, Sharief I, Budhiraja P, Saunders V, Hudgel DW. Early CPAP use identifies subsequent adherence to CPAP therapy. Sleep. 2007 Mar;30(3):320-4.

  PMID: 17425228 BACKGROUND

• Hwang D, Chang JW, Benjafield AV, Crocker ME, Kelly C, Becker KA, Kim JB, Woodrum RR, Liang J, Derose SF. Effect of Telemedicine Education and Telemonitoring on Continuous Positive Airway Pressure Adherence. The Tele-OSA Randomized Trial. Am J Respir Crit Care Med. 2018 Jan 1;197(1):117-126. doi: 10.1164/rccm.201703-0582OC.

  PMID: 28858567 BACKGROUND

• Kushida CA, Littner MR, Hirshkowitz M, Morgenthaler TI, Alessi CA, Bailey D, Boehlecke B, Brown TM, Coleman J Jr, Friedman L, Kapen S, Kapur VK, Kramer M, Lee-Chiong T, Owens J, Pancer JP, Swick TJ, Wise MS; American Academy of Sleep Medicine. Practice parameters for the use of continuous and bilevel positive airway pressure devices to treat adult patients with sleep-related breathing disorders. Sleep. 2006 Mar;29(3):375-80. doi: 10.1093/sleep/29.3.375.

  PMID: 16553024 BACKGROUND

• Lewis KE, Seale L, Bartle IE, Watkins AJ, Ebden P. Early predictors of CPAP use for the treatment of obstructive sleep apnea. Sleep. 2004 Feb 1;27(1):134-8. doi: 10.1093/sleep/27.1.134.

  PMID: 14998250 BACKGROUND

• Sawyer AM, Gooneratne NS, Marcus CL, Ofer D, Richards KC, Weaver TE. A systematic review of CPAP adherence across age groups: clinical and empiric insights for developing CPAP adherence interventions. Sleep Med Rev. 2011 Dec;15(6):343-56. doi: 10.1016/j.smrv.2011.01.003. Epub 2011 Jun 8.

  PMID: 21652236 BACKGROUND

• Shoib, S., Malik, J. A., Masoodi, S. R., & Rashid, A. (2018). Screening for comorbidities in obstructive sleep apnea. Journal of Clinical and Diagnostic Research, 12(1), VC01-VC03. https://doi.org/10.7860/JCDR/2018/27635.11071

  BACKGROUND

• Weaver TE, Maislin G, Dinges DF, Bloxham T, George CF, Greenberg H, Kader G, Mahowald M, Younger J, Pack AI. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. Sleep. 2007 Jun;30(6):711-9. doi: 10.1093/sleep/30.6.711.

  PMID: 17580592 BACKGROUND

• Duran J, Esnaola S, Rubio R, Iztueta A. Obstructive sleep apnea-hypopnea and related clinical features in a population-based sample of subjects aged 30 to 70 yr. Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):685-9. doi: 10.1164/ajrccm.163.3.2005065.

  PMID: 11254524 BACKGROUND

• Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.

  PMID: 23589584 BACKGROUND

• Franke C, Piezonna F, Schafer R, Grimm A, Loris LM, Schwaibold M. Effect of a digital patient motivation and support tool on CPAP/APAP adherence and daytime sleepiness: a randomized controlled trial. Sleep Biol Rhythms. 2023 Aug 17;22(1):49-63. doi: 10.1007/s41105-023-00479-9. eCollection 2024 Jan.

  PMID: 38469583 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Health Behavior; Behavior

Study Officials

• Christian Franke, Dr.med.

  Facharztzentrum Sonneberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: National, monocentric, prospective, randomized and controlled clinical trial with 2 arms. Arm 1: Control group - Standard Care (SC) Arm 2: Intervention group - Standard Care (SC) + digital patient support (DPS) tool

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 30, 2022
• Study Start: February 19, 2019
• Primary Completion: November 3, 2021
• Study Completion: March 31, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)