Best in category Best in Category
Disease Category: ,
Target Audience:

Clinical Effectiveness
Version: 1.6.6
Developer: Big Health, Ltd
Review Date: 2016-03-01
Cost: Free with in-app purchases ($9.99 for 1 week or $79.99 for 12 weeks)

Overall App Summary:

Sleepio is a best in class application for insomnia. It offers mobile and Web platforms. The program is modeled after the multi-week cognitive behavioral therapy insomnia (CBT-I) programs deployed across the world as the gold standard therapy for insomnia, which is the preferred method over medications for insomnia. CBT-I is a clinically proven method to improve insomnia, supported by many years of high quality research, including randomized controlled clinical trials (RCT). However, there is less evidence concerning the effectiveness of self guided CBT-I without clinician involvement. Sleepio itself was shown to be effective in a RCT with clinician involvement and results were published in an academic medical journal in 2012 (Espie C et al. Sleep 2012.) The program itself is somewhat tailored to the user’s specific sleep problems and sleep diary input, offering multi-week entertaining CBT-I sessions from a virtual therapist (a Scottish bespectacled cartoon!).   The app offers a comprehensive suite of lessons, tools, integration with fitness trackers, and visualization of sleep data. Sleepio is not intended to address medical questions and problems and should be used in conjunction with a supervising clinician..


App’s Intended Use:

This app aims to help users achieve better sleep through delivering elements of cognitive behavioral therapy and integrating real time data from wearable devices.


Who’s this app most useful for?

Sleepio appears most useful for any patient suffering from poor sleep, but focuses on insomnia.


How should one use it?

Importantly, Sleepio should be used in conjunction with a primary care, sleep medicine, or psychiatry health care provider.


Why should anyone use this app? Is it clinically relevant?

Sleepio’s intervention method is based on a clinically-proven method for insomnia called CBT-insomnia (CBT-I), which has undergone many years of high quality research, including various randomized control trials (RCTs) showing its benefit. A clinician should evaluate the patient and determine if their sleep problems are due to insomnia and therefore could be addressed by this app. There are many ways other than this app to receive CBT-I including other apps, computer programs, and from licensed mental health professionals.


Is there any published evidence that the app actually works?

The founder of Sleepio led a randomized controlled trial (RCT) in 2012* that showed Sleepio was more effective than a placebo method (placebo group) or no method (control group), improving insomnia in about 75% of study subjects who were in the intervention group. This was a formal clinical trial with healthcare providers, and it is not clear if Sleepio is effective as a direct to consumer offering, without healthcare provider guidance. Further, the published studies evaluated the web-based version, not the mobile application.

  • Espie et al. A Randomized, Placebo-Controlled Trial of Online Cognitive Behavioral Therapy for Chronic Insomnia Disorder Delivered via an Automated Media-Rich Web Application. Sleep 2012; 35(6): 769–781.


Regulatory Compliance

Not FDA cleared, but most likely exempt under Mobile Medical Applications guidance – enforcement discretion. However, it is not entirely certain how the FDA will decide to regulate this particular app, as it is a form of cognitive behavioral therapy.


What is the most important/ desirable feature of the app?

Sleepio should be appealing to insomnia patients because it is based on a previously-clinically proven method (CBT-i) and the app itself has been shown to be effective. Similar to office-based therapist CBT-I sessions, Sleepio interacts with the user, tailoring its advice accordingly. The interface and usability both foster a good experience for the user, though users should be prepared for a very long setup process and be committed to completing lessons. The sleep log is valuable and can integrate with fitness tracker data


How would you compare this app to others in it’s class?

Several available mobile or Web platforms employ similar (CBT-I) methods to Sleepio. Sleepio appears to be the best in class (for insomnia patients). Although all such apps are based on a clinically-proven method (CBT-I), Sleepio has the best user experience and the most relevant research data to support its use. The price of the program is comparable to other in-class apps at about $10 per week or $80 of the intended full 12-week program. However, the Veterans Administration has a free app (CBT-I Coach) that also offers CBT-I. CBT-I Coach may be worth investigating before paying for Sleepio.


If there’s a paid version, is it worth the upgrade?

To receive the entire benefit, users should purchase the multi-week program since the short trial does not allow enough time to complete all of the CBT-I components.


Security and Privacy

Password: Yes
Encryption: Not indicated in the privacy policy
Data Security: “We cannot guarantee the security of your data transmitted to the System”
Data Sharing: Per privacy policy, data may be shared with business associated, for research, for internal improvement of the program, if a threat to safety is detected, as required by law, and if the company is sold. If the company is sold, it is unclear how data will be shared or respected by the new owner.
Regulatory Compliance:

Adam Cohen

Dr. Adam B. Cohen, a Michigan native, is a neurologist & neuro-ophthalmologist at Massachusetts General Hospital in Boston, Massachusetts, where he is the Neurology Inpatient Medical Director and TeleNeurology Co-Director. He focuses on process innovation, digital health, and improving the efficiency of specialty health care delivery.

Conflicts of Interest:

Employment: Massachusetts General Hospital and Harvard Medical School; Consultant/ Advisor: Decibel Therapeutics, EM Gladiators LLC; Ownership: Expertaj; Research: Academic only; no private funding.

John Torous

Dr. John Torous is a clinical fellow and senior resident in psychiatry at Brigham and Women’s Hospital in Boston, Massachusetts who has a background in electrical engineering and computer sciences. He is chair of the American Psychiatric Association’s work group on smartphone apps and has also developed his own smartphone apps for clinical psychiatric research. He has published numerous papers on smartphone apps and app evaluation, and his work has been featured in Scientific American and Nature News. He is editor in chief of JMIR Mental Health, the leading journal for mental health and technology, and co-chair the Massachusetts Psychiatric Society's health information technology committee.

Adam Landman

Dr. Adam Landman, is an emergency physician and Chief Medical Information Officer at the Brigham and Women’s Hospital (BWH). Dr. Landman holds degrees in information systems and health care policy from Carnegie Mellon University and a medical degree from UMDNJ – Robert Wood Johnson Medical School. After medical school, he trained in emergency medicine at the University of California, Los Angeles, and completed the RWJ Foundation Clinical Scholars fellowship in health services research, where he worked on qualitative and quantitative studies on the adoption of health information technology (HIT) in the emergency department (ED) and prehospital settings.

Conflicts of Interest:

Employment: Brigham and Women's Hospital and Harvard Medical School; Consultant/ Advisor: None; Ownership: None; Research: CRICO.

Maulik Majmudar

Dr. Maulik Majmudar is a practicing cardiologist and Associate Director of the Healthcare Transformation Lab at Massachusetts General Hospital; and an Instructor at Harvard Medical School. He lectures at Massachusetts Institute of Technology in areas of healthcare innovation & entrepreneurship, as well as medical device design and development. Dr. Majmudar started his career as a medical student at Northwestern University Feinberg School of Medicine, completed resident training in Internal Medicine at The Johns Hopkins Hospital, and followed by a fellowship in Cardiovascular Medicine at Brigham and Women's Hospital at Harvard Medical School. You can follow him @mmajmudar

Conflicts of Interest:

Employment: Massachusetts General Hospital and Harvard Medical School; Consultant/ Advisor: AliveCor, BioFourmis, Cardiogram, EchoSense, Facebook, HUINNO, MC10, Nokia; Ownership: BioFourmis, Cardiogram, HiLabs, Quanttus; Research: EchoSense, GE Healthcare, MIT.

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